Medical device introduction system and associated imaging system and method

ABSTRACT

A medical device introduction system includes an introducer comprising a handle. An introducer tube extends from the handle to a distal end and defines longitudinally-extending lumens. An imaging system, engageable with the introducer, comprises a body member having a light source and receivable by the handle. A proximal portion of a flexible tubular member is engaged with the body member, and is positionable in one lumen. An imaging device, engaged with the distal portion and in communication with the body member, is directed in an imaging direction to capture an image outwardly of the distal portion. A plurality of light transmission devices extends through the tubular member from the light source, and distal ends thereof are arranged about the imaging device about the distal portion of the tubular member to direct the light transmitted from the light source in the imaging direction. An associated system and method are also provided.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation-in-part of U.S. patentapplication Ser. No. 14/157,307; filed Jan. 16, 2014 (now U.S. PatentApplication Publication No. US 2014/0200402); which claims priority toU.S. Provisional Patent Application No. 61/753,413; filed Jan. 16, 2013;the contents of which are incorporated herein by reference in theirentirety

BACKGROUND

Field of the Disclosure

The present disclosure relates to medical device introduction systemsfor separately introducing and independently controlling multiplecooperating medical devices in interior body regions and, moreparticularly, to a medical device introduction system and associatedimaging system and method capable of being implemented in such a medicaldevice introduction system.

Description of Related Art

In recent years, medical procedures have advanced to stages where lessand less invasive, or minimally invasive, surgeries, diagnosticprocedures, exploratory procedures, or other medical procedures havebeen desired and demanded by patients, physicians, and payers. Toaccomplish these desires and demands, various medical devices andinstrumentation have been developed, such as cannulas or micro-cannulas,various catheter devices, micro-surgical instrumentation and implants,medical introducers, imaging devices such as fiberoptic scopes, andother related endoscopic devices.

In situations in which minimally invasive procedures are used, spacewithin an interior body region, for example, an organ, opening, cavity,passageway, or vessel, can become more and more constrained. As aresult, operating within small spaces with a plurality of medicaldevices, such as scopes, dilating and cutting instruments, fluids,catheters, implants, and the like, can become difficult to manage. Whenperforming a procedure with a plurality of medical devices, thepositioning, controlling, manipulating, and handling of the variousmedical devices during the procedure can limit a physician's ability toperform as well as capable. That is, the design and construction of amedical device can limit a physician's ability to view a target site,maneuver within a space, transition between procedures, and/or performadditional procedures. Managing the use of multiple devices in aprocedure can pose even greater difficulty to a single physician whodesires to perform a procedure, often without assistance or with limitedassistance, in an office or outpatient setting so as to avoid the timeand expense of hospital utilization for such procedures.

Conventional medical devices having optical capabilities, such asconventional endoscopes, can have other disadvantages. The opticalcapabilities can be limited due to various factors, including, forexample, the anatomical structures about which the scopes aremaneuvered, and the movement and/or control together of both the imagingdevice and a delivery device and the resulting loss in orientation in aninterior body region. For example, optical capabilities withconventional endoscopes typically used in hysteroscopy procedures areoften limited in such ways, making it difficult for the physician toknow whether what is being viewed is up or down. Such conventionalendoscopes and associated delivery devices are often complex and requireextended learning to operate effectively. In addition, many conventionalendoscopes and delivery devices are reusable and can be very expensiveto purchase and to re-sterilize after each use. As a result, physiciansoften elect not to perform diagnostic and/or therapeutic procedures in amedical office or outpatient setting that could otherwise be performedto the patient's advantage in those settings.

During use in medical procedures, introducer instruments, sheaths,endoscopes, and working catheters and cannula can be exposed to variousbacteria, viruses, and other microorganisms, and to potentially diseasecarrying media. These microorganisms can be trapped in such devices,particularly in lumens, and transferred to subsequent patients or users.Sterilization methods can be employed on such devices that are reusablein an attempt to disinfect and eliminate microorganisms for subsequentuse of the devices. However, some surgical devices contain very smalland/or narrow working channels or lumens for performing intricatemedical procedures. These small and/or narrow working channels can bedifficult to clean and sterilize. If not effectively eliminated, thesematerials may be transferred to, and potentially cause harmfulinfections to, other patients or medical personnel through subsequentuse of the devices.

In addition to the problems of potential disease transmission and lackof disposability, conventional reusable medical introducer, endoscopes,and the like are subjected to repeated use over prolonged periods. Theprecision of manipulation and movement in endoscopes and steerablemedical devices is often essential for conducting complicated diagnosticand therapeutic medical procedures generally performed with suchdevices. Some reusable devices containing steering mechanisms oftenrequire precision calibration. Further, these devices are regularlysubjected to sterilization with heat or chemicals. To accomplish theseobjectives, conventional reusable devices are often made of stainlesssteel or other durable materials that are costly. In addition, despitebeing designed for repeated use, such conventional intricate reusabledevices, in particular, such devices that incorporate visualizationcomponents, often require regular replacement, further adding to thecost of such devices.

SUMMARY

The above and other issues are addressed by aspects of the presentdisclosure which, in one aspect, provides a medical device introductionsystem adapted to be at least partially insertable into an interior bodyregion of a patient. Such a system comprises a medical introducercomprising a handle and an elongate introducer tube extending from thehandle to a distal end, wherein the introducer tube defines a pluralityof lumens extending longitudinally therein from the handle to the distalend. A medical imaging system is configured to be operably engageablewith the medical introducer. Such a medical imaging system comprises abody member including a light source configured to emit light, whereinthe body member is configured to be received by the handle of themedical introducer. A flexible elongate tubular member has a proximalportion operably engaged with the body member, and extends to an opposeddistal portion. The tubular member is configured to be insertablethrough the handle and positionable in one of the lumens, so as toextend to the distal end of the introducer tube. An imaging device isengaged with the distal portion of the tubular member, and is configuredto be in communication with the body portion. The imaging device isarranged so as to be directed, and to be capable of capturing an image,in an imaging direction outwardly of the distal portion. A plurality oflight transmission devices extends from the light source and through thetubular member to respective distal ends thereof disposed about thedistal portion of the tubular member. The light transmission devices areconfigured to receive the light from the light source and to transmitthe light to the distal ends thereof. The distal ends of the lighttransmission devices are arranged about the imaging device about thedistal portion of the tubular member so as to direct the lighttransmitted from the light source in the imaging direction.

Another aspect of the present disclosure provides a medical imagingsystem adapted to be at least partially insertable into an interior bodyregion of a patient. Such a system comprises a body member including alight source configured to emit light. A flexible elongate tubularmember has a proximal portion operably engaged with the body member, andextends to an opposed distal portion. An imaging device is engaged withthe distal portion of the tubular member and is configured to be incommunication with the body member. The imaging device is arranged so asto be directed, and to be capable of capturing an image, in an imagingdirection outwardly of the distal portion. A plurality of lighttransmission devices extend from the light source and through thetubular member to respective distal ends thereof disposed about thedistal portion of the tubular member. The light transmission devices areconfigured to receive the light from the light source and to transmitthe light to the distal ends thereof. The distal ends of the lighttransmission devices are arranged about the imaging device about thedistal portion of the tubular member so as to direct the lighttransmitted from the light source in the imaging direction.

Yet another aspect of the present disclosure provides a method offorming a medical imaging system adapted to be at least partiallyinsertable into an interior body region of a patient. Such a methodcomprises operably engaging a proximal portion of a flexible elongatetubular member with a body member including a light source configured toemit light, wherein the tubular member extends to an opposed distalportion. An imaging device is engaged with the distal portion of thetubular member such that the imaging device is in communication with thebody member, and such that the imaging device is arranged to bedirected, and to be capable of capturing an image, in an imagingdirection outwardly of the distal portion. A plurality of lighttransmission devices is engaged with the light source such that thelight transmission devices extend through the tubular member torespective distal ends thereof disposed about the distal portion of thetubular member, wherein the light transmission devices are configured toreceive the light from the light source and to transmit the light to thedistal ends thereof, and such that the distal ends of the lighttransmission devices are arranged about the imaging device about thedistal portion of the tubular member to direct the light transmittedfrom the light source in the imaging direction.

Further features and advantages of the present disclosure are set forthin more detail in the following description.

BRIEF DESCRIPTION OF THE DRAWINGS

Having thus described the disclosure in general terms, reference willnow be made to the accompanying drawings, which are not necessarilydrawn to scale, and wherein:

FIG. 1 is a perspective view of a medical device introduction system inan embodiment of the present invention;

FIG. 2 is a perspective view of the medical introducer shown in FIG. 1,showing a plug seal in the working channel in an embodiment of thepresent invention;

FIG. 3 is a view of the medical introducer shown in FIG. 1, showing aplug adapter with seal in the working channel in an embodiment of thepresent invention;

FIG. 4 is a close-up, perspective view of the manifold of the medicalintroducer shown in FIG. 1, in an embodiment of the present invention;

FIG. 5 is a cross-sectional view taken along the lines 5-5 of the lumensin the manifold shown in FIG. 4, in an embodiment of the presentinvention;

FIG. 6 is a close-up, perspective view of the steerable working channeldevice position controller shown in FIG. 1, in an embodiment of thepresent invention;

FIG. 7 is a cross-sectional view taken along the lines 7-7 in FIG. 6 ofthe internal components of the steerable working channel device positioncontroller in an embodiment of the present invention;

FIG. 8 is a close-up perspective view of the steerable working channeldevice proximal port shown in FIGS. 1 and 6 in an embodiment of thepresent invention;

FIG. 9A shows a top view of the medical introducer and steerable workingchannel device shown in FIG. 1, in an embodiment of the presentinvention wherein the position controller is in a distal position andthe distal end portion is deflected to the left;

FIG. 9B shows a top view of the medical introducer and steerable workingchannel device shown in FIG. 1, in an embodiment of the presentinvention wherein the position controller is in a medial position andthe distal end portion is deflected to the left;

FIG. 9C shows a top view of the medical introducer and steerable workingchannel device shown in FIG. 1, in an embodiment of the presentinvention wherein the position controller is in a proximal position andthe distal end portion is fully retracted;

FIG. 9D shows a top view of the medical introducer and steerable workingchannel device shown in FIG. 1, in an embodiment of the presentinvention wherein the position controller is in a medial position andthe distal end portion is deflected to the right;

FIG. 9E shows a top view of the medical introducer and steerable workingchannel device shown in FIG. 1, in an embodiment of the presentinvention wherein the position controller is in a distal position andthe distal end portion is deflected to the right;

FIG. 10 is a view of the medical introducer and steerable workingchannel device shown in FIG. 1, illustrating positioning of thesteerable working channel tube in a uterine cavity in an embodiment ofthe present invention;

FIG. 11 is a close-up view of the endoscope and camera shown in FIG. 1,in an embodiment of the present invention;

FIG. 12 is a cross-sectional view of a steerable working channel showingsteering wire lumens and areas of the working channel tube havingdifferent relative durometers in an embodiment of the present invention;

FIG. 13 is a view of a medical introducer tube having a lift wire lumenin an embodiment of the present invention;

FIG. 14 is a view of a medical introducer tube showing a lumenconfiguration having a large scope lumen and three smaller lumens fordelivering a medical device and for fluids in an embodiment of thepresent invention;

FIG. 15 is a side view of a medical device introduction system having anaccessory device support attached thereto, the accessory device supportsupporting an implant delivery device, in an embodiment of the presentinvention;

FIG. 16 is a view of a continuous flow examination sheath useful in anembodiment of the present invention, showing both assembled andunassembled views;

FIG. 17 is a view of a single flow examination sheath useful in anembodiment of the present invention, showing both assembled andunassembled views;

FIG. 18 is a view of a preformed delivery tube useful in an embodimentof the present invention, showing both assembled and unassembled views;

FIG. 19 is a view of a medical device that has a slider and a railassociated with the medical device;

FIG. 20 is a view of a bent introducer tube;

FIG. 21 is a view of the introducer tube with an accompanying bentsheath;

FIG. 22 is a view of the introducer tube with an accompanying bentsheath wherein distal tip of the introducer tube and the working channelmedical device are visible;

FIG. 23 is a view of a uterus wherein the introducer tube is accessingthe left osteum and fallopian tube;

FIG. 24 is a view of a uterus wherein the introducer tube is accessingthe right osteum and fallopian tube;

FIG. 25 is a view of a manifold wherein the manifold contains a sealthat is present at the location of the working channel;

FIGS. 26A and B show an “r” curve and an “s” curve tip, respectively;

FIG. 27 shows an embodiment of the medical introducer device;

FIG. 28 shows a perspective view of the various lumens as they enterinto the modular manifold;

FIG. 29 shows a perspective view of the various parts of the modularmanifold, the manifold base, the seal and the manifold cover;

FIG. 30 shows the modular manifold in an unassembled state and anassembled state, with the manifold base and the manifold cover separatedand then joined;

FIG. 31 shows the modular manifold with lumen core pins as they are usedin the process of assembling the modular manifold;

FIG. 32 shows the modular manifold in a vertical position, which showsan embodiment of a process that allows the gluing of the manifold baseand the manifold cover (with or without a seal);

FIG. 33 schematically illustrates an imaging system adapted for use witha medical device introduction system, according to various aspects ofthe present disclosure;

FIG. 34 schematically illustrates a cross-section of a flexible elongatetubular member adapted for use with a medical device introductionsystem, according to various aspects of the present disclosure; and

FIG. 35 schematically illustrates a cross-section of a flexible elongatetubular member having an imaging device mounted therein, and adapted foruse with a medical device introduction system, according to variousaspects of the present disclosure.

DETAILED DESCRIPTION

The present disclosure now will be described more fully hereinafter withreference to the accompanying drawings, in which some, but not allaspects of the disclosure are shown. Indeed, the disclosure may beembodied in many different forms and should not be construed as limitedto the aspects set forth herein; rather, these aspects are provided sothat this disclosure will satisfy applicable legal requirements. Likenumbers refer to like elements throughout.

Some embodiments of the present invention can provide a medical deviceintroduction system and/or method. For example, an illustrativeembodiment of a medical device introduction system and/or method caninclude a medical introducer, a separate imaging system, and/or aseparate working channel device. In such an embodiment, each of themedical introducer, the imaging system, and the working channel devicecan be movable independent of the other.

Minimally invasive surgical procedures have been developed that can beused in many diagnostic and/or therapeutic medical procedures. Suchminimally invasive procedures can reduce pain, post-operative recoverytime, and the destruction of healthy tissue. In minimally invasivesurgery, the site of pathology can be accessed through portals ratherthan through a significant incision, thus preserving the integrity ofintervening tissues. These minimally invasive techniques also oftenrequire only local anesthesia.

Some embodiments of the present invention can provide systems, devices,kits, and methods useful for easily and effectively accomplishingminimally invasive gynecological procedures, for example, ahysteroscopy. Such systems, devices, kits, and methods may be adaptedfor use in many interior body regions, wherever introduction of medicaldevices may be required for a therapeutic or diagnostic purpose.

As used in this specification and the appended claims, “proximal” isdefined as nearer to a point of reference such as an origin, a point ofattachment, or the midline of the body. As used in this specificationand the appended claims, “distal” is defined as farther from a point ofreference, such as an origin, a point of attachment, or the midline ofthe body. Thus, the words “proximal” and “distal” refer to, for example,direction, nearer to and farther from, respectively, an operator (forexample, surgeon, physician, nurse, technician, etc.) who inserts amedical device into a patient, with the distal end, or tip, of thedevice inserted inside the patient's body. For example, the end of amedical device inserted inside the patient's body is the distal end ofthe medical device, while the end of the medical device outside thepatient's body is the proximal end of the medical device.

As used in this specification and the appended claims, the singularforms “a,” “an,” and “the” include plural referents unless the contextclearly dictates otherwise. Thus, for example, the term “a lumen” isintended to mean a single lumen or a combination of lumens. For thepurposes of this specification and the appended claims, unless otherwiseindicated, all numbers expressing quantities, conditions, and so forthused in the specification are to be understood as being modified in allinstances by the term “about.” Accordingly, unless indicated to thecontrary, the numerical parameters set forth in this specification areapproximations that can vary depending upon the desired propertiessought to be obtained by embodiments of the present invention. At thevery least, and not as an attempt to limit the application of thedoctrine of equivalents to the scope of the claims, each numericalparameter should at least be construed in light of the number ofreported significant digits and by applying ordinary roundingtechniques.

Notwithstanding that the numerical ranges and parameters setting forththe broad scope of embodiments of the invention are approximations, thenumerical values set forth in the specific examples are reported asprecisely as possible. Any numerical value, however, inherently containscertain errors necessarily resulting from the standard deviation foundin their respective testing measurements. Moreover, all ranges disclosedherein are to be understood to encompass any and all sub-ranges subsumedtherein. For example, a stated range of “1 to 10” should be consideredto include any and all sub-ranges between (and inclusive of) the minimumvalue of 1 and the maximum value of 10. That is, a stated range of “1 to10” should be considered to include, for example, all sub-rangesbeginning with a minimum value of 1 or more, such as 1 to 6.5, andending with a maximum value of 10 or less, such as 5.5 to 10.Additionally, any reference referred to as being “incorporated herein”is to be understood as being incorporated in its entirety.

As used in this specification and the appended claims, an “interior bodyregion” can be a body cavity, a body space or potential space, a vein,an artery, a vessel, a duct, a pathway, an organ, or any interior sitein a patient's body accessible with a medical introducer.

As used in this specification and the appended claims, an endoscope isdefined as an instrument for examining an interior body region.Endoscopes are generally tools used to view within a portion of theanatomy through an open end of a tube. Flexible endoscopes may beutilized in certain deformable anatomical structures, for example,arteries, ureters, and the common bile duct. Endoscopes can be used tolook directly through an objective lens or in conjunction with videocameras attached remotely to the scope for viewing a portion of thehuman body. Rod lens systems may also be used with some endoscopes toview images. In other endoscopes, the image may be gathered at thedistal end by a lens and transferred to a proximal objective lens usingfiber optic bundles.

Some embodiments of a medical device introduction system 10 and methodof the present invention can include a medical introducer 20, a separateimaging system 60, and/or a separate working channel device 40. Themedical introducer 20 can include a proximal end 11, a distal end 12, ahandle 21, and an elongate introducer tube 23 extending from the handle21. The introducer tube 23 can include and define a plurality of lumensextending longitudinally therein. The medical introducer 20 may beinserted into an interior body region of a patient. The separate imagingsystem 60 may be inserted through the handle 21 and positioned in apredetermined one of the plurality of lumens. The imaging system 60 canhave an interface with the handle 21 such that each of the imagingsystem 60 and the medical introducer 20 is movable independent of theother. The separate working channel device 40 can include an elongateworking channel tube 42 and a position controller 41. The workingchannel tube 42 can include at least one lumen extending the lengththereof defining a working channel. The position controller 41 can beconfigured to control positioning of the working channel tube 42. Theworking channel device 40 may be removably connectable to the handle 21and positioned in another predetermined one of the plurality of lumens.In some embodiments of the present invention, each of the medicalintroducer 20, the imaging system 60, and the working channel device 40can be movable independent of the other.

In such an embodiment, the imaging system 60 can be placed into adesired position for viewing a procedure. The imaging system 60, such asthe camera 61, can be held in a steady, or fixed, position, while thedistal portion 12 of the steerable working channel 40 can be positioned,or re-positioned, (extended, retracted, or deflected) independent of theimaging system 60. In this manner, the starting reference point, such asthe “horizon” and/or depth of the steerable working channel 40 in theinterior body region can be held constant by the imaging system 60. As aresult, the true movement of the steerable working channel relative to acertain starting point can be gauged. Alternatively, the steerableworking channel device 40 can be held in a fixed position so as tomaintain a fixed orientation, or reference point, of the working channeltube portion 42 of the working channel in the interior body region.While the steerable working channel device 40 is held in a constantposition, the position of imaging system 60 can be adjusted independentof the steerable working channel device 40. In this manner, the truemovement of the imaging system 60 relative to a certain starting pointcan be gauged.

In addition, while holding the imaging system 60 in a fixed position,the medical introducer 20 can be independently rotated about itslongitudinal axis 33 if desired. Rotation of the medical introducer 20may be desired for purposes such as adjusting the starting position ofthe steerable working channel tube 42 prior to extending or deflectingthe distal tip of the working channel tube 42, or reorienting fluidoutflow at a target area in the interior body region. In this manner,the true movement of the medical introducer 20 relative to a certainstarting point can be gauged. Likewise, if desired, the medicalintroducer 20 and the attached steerable working channel device 40 canbe held in a constant position so as to maintain a fixed orientation, orreference point, of the working channel tube 42 and the working channelin the interior body region. While the medical introducer 20 and theattached steerable working channel device 40 can be held in a constantposition, the position of imaging system 60 can be adjusted. In thismanner, the true movement of the imaging system 60 relative to a certainstarting point can be gauged.

This combination of separate and cooperating components of embodimentsof the present invention allows for more precise control of instrumentpositioning and delivery of materials, such as fluids, medications, andimplants, in an interior body region. Independent position control andmovement of the imaging system 60 relative to the medical introducer 20and to the steerable working channel device 40 allows optimalvisualization of a target operative site within an interior body region.

An embodiment of the medical device introduction system 10 of thepresent invention can include a medical introducer 20. As used herein, a“medical introducer” is defined as an instrument used to introduce amedical device, for example, a tube, stent, catheter, and/or surgicalinstrument, into an interior body region of a human or animal.

In some embodiments of the present invention, the medical introducerdevice 20 can include the handle 21 comprising an oval-shaped ring ofmaterial having an open interior, a proximal end, and a distal end. Theintroducer 20 can further include an elongate introducer tube 23extending from the distal end 15 of the handle 21 and having a pluralityof lumens extending longitudinally therein. The proximal end 14 of thehandle 21 can be configured to receive at least one fluid tube 24, 25and the imaging system 60 through the handle 21. The distal end 15 ofthe handle 21 can be adapted to connect to the introducer tube 23, asdescribed herein. Such a medical introducer 20 can be inserted into aninterior body region of a patient.

The plurality of lumens in a medical introducer tube 23 can include ascope lumen 34, at least one working lumen 35, and at least one fluidlumen 36 separate from the scope lumen 34 and the working lumen(s) 35.The medical introducer 20 can further include a fluid inflow tube 24routed through the proximal end of the handle 21 and in fluidcommunication with one of the at least one fluid lumen 36. The medicalintroducer 20 can further include the fluid outflow tube 25 routedthrough the proximal end of the handle 21 and in fluid communicationwith another one of the fluid lumen(s) 36. In certain embodiments, thediameter of the working lumen 35 can be larger than the diameter of theother lumens 34, 36.

In an embodiment, the working lumen 35 can accommodate medical devices,which can place medications and/or provide implants to an interior bodyregion. However, these medical devices sometimes need to be removedand/or resubmitted. When this occurs, there is the danger of backflowfrom fluids from the interior body region. Accordingly, in oneembodiment, the medical devices of the present invention also possess amanifold 250 and seal 251 as shown in FIG. 25, which will aidameliorating, diminishing and/or eliminating the backflow of fluids. Itshould be noted the similarities between FIG. 25 and for example, FIG.13, wherein the manifold 250 is designed in a way to accommodate thevarious lumens as shown in FIG. 13. Note that the working lumen 35 isthe one that may have medical devices inserted and removed so themanifold 250 contains the seal 251 in the position that is designed toaccommodate these medical devices. The seal 251 in some embodiments hasflaps associated with it that allow the passage of the medical devicebut preclude the passage of fluid one the medical device has beenremoved. The manifold 250 may be made of a plastic that provides themedical device with additional structural integrity that might nototherwise be present.

The medical introducer 20 can be utilized to perform diagnosticprocedures, for example, by using the dedicated fluid-in and fluid-outlumens 36 and tubes 24, 25, respectively, to irrigate an interior bodyregion and retrieve a sampling of washings from the targeted region fordiagnostic tests. Alternatively, or in addition, the medical introducer20 can be utilized to perform therapeutic procedures, for example, byusing the dedicated working lumen 35 to introduce a device for placing amedication and/or an implant into an interior body region.

The fluid-in tube 24 can include a pinch clamp 26 for on-off regulationof fluid delivery into the interior body region. The fluid-out tube 25can include a roller clamp 27 for graduated regulation of fluid flow outof the interior body region. In other embodiments, regulation of fluidflow on both the fluid-in tube 24 and the fluid-out tube 25 can bemanaged by different regulation mechanisms, for example an electronicfluid pump for fluid delivery or a suction device for fluid removal.Separate dedicated fluid lumens 36 and tubes 24, 25 in embodiments ofthe present invention can allow better fluid flow, for example, morecontinuous fluid flow, than conventional medical device introducers thatoften deliver fluid to an interior body region through a working lumen35 in which a medical device may be placed simultaneously.

The medical introducer 20 can include a modular manifold 22 integrallyformed on the proximal end of the introducer tube 23 and have acorresponding plurality of lumens aligned with the plurality of lumensin the introducer tube 23. The manifold 22 may be removably connected tothe handle 21 such that the manifold 22 and introducer tube 23 areinterchangeable in the handle 21 with other manifolds 22 and introducertubes 23.

As shown in FIG. 4, the handle 21 can be connected to the manifold 22 bysnapping a groove, or cut-out in the distal end 15 of the handle 21about a correspondingly shaped handle receiving groove 48 in themanifold 22. The manifold 22 can include a handle support 49 extendingdownwardly from the bottom of the manifold below the handle receivinggroove 48. When the handle 21 is removably snap fit about the handlereceiving groove 48 in the manifold 22, the distal end 15 of the handle21 can abut the handle support 49 to provide further support of thepositioning of the handle 21 on the manifold 22.

In an embodiment, the manifold 22 (a slightly different embodiment of amanifold 250 is also shown from a top down angle in FIG. 25) may beintroduced in a region between the handle and the proximal end of theintroducer tubes 23. In one embodiment, the manifold is removable. Inalternate embodiments, the manifold may be attached with medically safeglues that are thermally attached. One potential drawbacks to the use ofthermal glues is that in the manufacturing process, one needs to makesure that appropriate plastics are used that have melting points abovethe thermal set point of the glue. Otherwise, one risks excessive costs(and possibly defective medical devices) that result from meltingplastic (e.g., holes in the plastic lumens, etc.). In a furtherembodiment, the manifold may be attached with medically safe glue thatrelies on setting by the administration of UV light (or some otherwavelength from the electromagnetic spectrum that allows the glue toset). The advantage of using these UV setting glues is that one does nothave to worry about plastic melting on the medical device.

In an embodiment in which a separate imaging system 60 is insertedthrough the handle 21 and positioned in a predetermined lumen (34) inthe medical introducer 20, the imaging system 60 can have an interfacewith the handle 21 such that each of the imaging system 60 and themedical introducer 21 is movable independent of the other. In certainembodiments, the medical introducer device 20 can cooperate with aseparate working channel device 40. The separate working channel device40 can comprise an elongate working channel tube 42 having at least onelumen extending the length thereof defining a working channel and aposition controller 41 for controlling the position of the workingchannel tube 42. The working channel device 40 can be removablyconnected to the handle 21 and positioned in a predetermined lumen (35)in the medical introducer 21 separate from the imaging system 60, suchthat each of the medical introducer 20, the imaging system 60, and theworking channel device 40 is movable independent of the other.

In some embodiments, the medical introducer device 20 can be disposable.In some embodiments, at least a portion of the medical introducer device20 can be translucent such that passage of materials therethrough can beviewed.

The introducer tube 23 can include a proximal 11 portion having a firstdurometer and a distal portion 12 having a second durometer. As usedherein, durometer is defined as a degree of hardness; a harder materialcomprises a higher durometer than a softer material. The seconddurometer can be lower than the first durometer so as to allowdeflection of the distal portion 12 for controllable access to a targetarea in the interior-body region. The introducer tube distal portion caninclude a distal tip 13 having a first diameter smaller than a seconddiameter of the remainder of the introducer tube 23, such that thesmaller first diameter is adapted to seal about a device extendingbeyond the distal tip 13. The introducer tube 23 can further include afluid lumen 36 comprising a wall having a third durometer that is higherthan the second durometer of the distal portion 12 so as to preventcollapsing of the fluid lumen 36 when the distal portion 12 of theintroducer tube 20 is deflected.

In some embodiments, the introducer handle 21 can have a size adapted tobe readily held in a hand of a user. In some embodiments, the introducerhandle 21 can further include a plurality of raised grips 32 on anoutside surface of the handle 21 to assist in manipulating the handle21.

Embodiments of the medical introducer 20 can have varied numbers, sizes,and configurations of lumens 34, 35, 36 in the introducer 20.Embodiments of the medical introducer 20 can have various lengths,depending on the particular interior body region it is designed toaccess and on the particular medical procedure for which it is designed.For example, in some embodiments, the medical introducer 20 can includea 7 French size dedicated working lumen 35 so as to support passage oflarger devices than conventional multiple lumen delivery devices havingthe same outside diameter. This advantage is provided by having asmaller dedicated scope lumen 34 and extruding the manifold 22 andintroducer tube 23 with smaller wall thicknesses.

In certain embodiments, the introducer handle 21 can include a scopeconnector 28 located on the proximal end 14 of the handle 21. The scopeconnector 28 can be longitudinally aligned with the one of the pluralityof lumens (34) in the introducer tube 23. The imaging system 60 can besecurely connected to the scope connector 28, for example, with a luerlock fitting. When the imaging system 60 is securely connected to thescope connector 28, the imaging system 60-medical introducer 20interface is adapted to allow the imaging system 60 to rotateindependent of movement of movement of the medical introducer 20.

The medical introducer 20 can be formed in a molding process by aplastic or polymeric material. The medical introducer 20 can be formedfrom materials and in such a manner so as to have most, or all,components be translucent, thereby enabling visualization andvisually-guided passage of instruments and fluids through the introducer20. Such visualization may also assist with establishing delivery routesas discussed herein. Further, such visualization may allow for theidentification of a gaseous material (e.g. air) within a channel, and/orconfirmation of the absence of such gaseous material within a channel.

The lumen 35 in the medical introducer 20 designed for inserting thesteerable working channel device 40 can be sealed with a sealingmechanism. Such a seal 37 can be a duckbill seal or a one-way valve,including a luer fitting. The seals 37 can provide frictional orabutting contact with the inner surface of the working lumen 35 in themanifold 22. Such a seal 37 mechanism can allow medical devices and/orfluid, for example, gas or liquid, to pass through the seal mechanism 37toward the distal end of the introducer tube 23, and can inhibit fluidfrom passing from the interior body region through the proximal end 11of the introducer tube 23.

In certain embodiments, the medical introducer 20 can be inserted intoan interior body region with a trocar system (not shown). A trocar cancomprise a cannula that may have a sharp distal tip for creating apercutaneous path to the interior body region. Once the trocar is in adesired position in or adjacent the target interior body region, themedical introducer 20 can be inserted through the trocar to the targetsite. In such an application, a portion of the patient's body needs tobe penetrated or opened where a body cavity does not provide a readyopening. Such a trocar system can be used, for example, for prostatesurgery. In this manner, a trocar system, or other endoscopic device,can assist in providing a path through which the medical introducer 20can enter the portion of the interior body region of a patient intowhich a medical procedure is desired to be performed.

The medical introducer 20 can be utilized to perform diagnosticprocedures, for example, by using the dedicated fluid-in and fluid-outlumens 36 and tubes 24, 25 to irrigate an interior body region andretrieve a sampling of washings from the targeted region. Alternatively,or in addition, the medical introducer 20 can be utilized to performtherapeutic procedures, for example, by using the dedicated workinglumen 35 to introduce a device for placing an implant into an interiorbody region.

In an alternative embodiment, the medical introducer 20 can furtherinclude an inflatable portion associated with the distal portion of theintroducer tube 23. The inflatable portion can be utilized to distend orenlarge a cavity, space, or portion of an interior body region and/orblock fluid passage from the interior body region when the introducertube 23 is positioned therein.

In another aspect of the present invention, some embodiments can includea working channel device 40 that is steerable. The entire length of theworking channel tube 42 can be flexible. Alternatively, a substantialportion of the working channel tube 42 can be generally rigid, orsemi-rigid, and a distal portion 12 of the working channel tube 42 canbe flexible. In such embodiments, as shown in FIGS. 1, 6, 7, and 9, theworking channel tube 42 can include a flexible distal portion 12 adaptedfor steering to selected positions. In such embodiments, the positioncontroller 41 can be operably connected to the working channel tubedistal portion 12 and slidable within the introducer handle 21 formoving the working channel tube distal portion 12 in distal and proximaldirections. In addition, the position controller 41 can be actuatable tosteer the flexible distal portion 12 of the working channel tube 42 inpredetermined directions and amounts. For example, the predetermineddirection of steering can be in a plane generally parallel to an uppersurface of the position controller 41.

In embodiments of a steerable working channel device 40, the device 40can include, for example, at least two steering wires (not shown). Eachsteering wire has a distal end connected to the distal tip 13 of theworking channel tube 42. Each steering wire can extend through theworking channel tube 42, and have a proximal end operably connected tothe position controller 41. In this way, the position controller 41 canbe actuated to manipulate the distal portions 12 of the working channeltube 42.

In certain embodiments of the steerable working channel tube 42, theposition controller 41 can further include a circular, lower housing 51having an upwardly extending hollow hub 54 and a cooperating circular,upper housing 50 having a downwardly extending rotor 55 rotatinglyseated inside the hollow hub 54. Each of the steering wires can beconnected to an opposite side of the position controller rotor 55 suchthat rotation of the upper housing 50 causes rotation of the rotor 55inside the hub 54, resulting in the distal end of the steering wire onone side of the rotor 55 to retract so as to deflect the distal tip 13at an angle laterally away from the longitudinal axis 33 of the workingchannel tube 42.

As described herein, the introducer handle 21 can comprise anoval-shaped ring of material having an open interior. The open handle 21can have a plurality of detents (not shown) on the inner surface of thehandle 21 from the proximal position 31 to the medial position 30 to thedistal position 29. The lower housing 51 of the position controller 41can further include a downwardly extending bracket 52 adapted tofriction fit in the inner surface of the handle 21 and a securing flange53 extending outwardly from the bracket 52 adapted to friction fit abouta bottom of the handle 21. Accordingly, the position controller 41 canbe slidingly engageable with the detents (not shown) so as to secure theposition, of the working channel tube distal portion 12 and distal tip13 along the longitudinal axis 33 of the working channel tube 42.

The position controller 41 can further include an automatic brakingmechanism (not shown). For example, the braking mechanism can comprise asoft material on the outer surface of the upper housing rotor 55 and/orthe outer surface of the lower housing hub 54 so as to providesufficient friction to hold the upper housing 50 in position relative tothe lower housing 51 when released by a user.

In some embodiments, the working channel tube 42 can further include aproximal 11 portion having a first durometer and a distal 12 portionhaving a second durometer. The second durometer can be lower than thefirst durometer so as to allow deflection of the distal portion 12 forimproved access to a target area in the interior body region. Theworking channel tube distal portion 12 can further include the distaltip 13 having a first diameter smaller than a second diameter of theremainder of the working channel tube 42. The smaller first diameter canbe adapted to seal about a device extending beyond the distal tip 13.Each or either of the proximal or distal portions may, in someembodiments, comprise a plurality of durometers to enhance steering.

It should be appreciated that other mechanisms for steering, forexample, two finger deflection, may be utilized in some embodimentswithout departing from the present invention.

In certain embodiments, the working channel device 40 can furtherinclude at least one access port 38 having a seal 39. The sealed accessport 38 can be connected to the proximal end 11 of the working channeltube 42 for controllable access to the steerable working channel.

The position controller 41 can have a size adapted to be readily held ina hand of a user. The position controller 41 can further include aplurality of grips 47 on lateral edges of the position controller 41 toassist a user in manipulating the position controller 41.

In certain embodiments, the working channel can be utilized to deliverinstruments, fluids, medications, implants, or other materials into aninterior body region. The steerable working channel device 40 can bepositioned in at least one other of the plurality of lumen (35) of themedical introducer 20 so that the separate steerable working channeldevice 40 and the imaging system 60 are independently controllable. Insome embodiments, the working channel device 40 can be disposable andintended for a single use.

An example of an embodiment of a flexible distal portion 12 and steeringwire configuration is shown in FIG. 12. In this embodiment, the workingchannel tube of the steerable working channel device 40 can comprise aproximal 11 insertion portion, a distal portion 12, and a distal tip 13.The proximal 11 insertion portion can be formed of a semi-rigid material67, for example, pellethane having a 75 durometer hardness rating. Thedistal portion 12 can be formed of a combination of a relatively hardermaterial 67, such as a 75 durometer pellethane, and a relatively softer,flexible material 68, such as pellethane having a 55 durometer. Theportion of the distal portion 12 having different relative hardness canbe co-extruded. The distal tip 13 can be formed of a semi-rigid material67, which can be the same material from which the proximal 11 insertionportion is formed (for example, pellethane having a 75 durometer). Incertain embodiments, other materials can be used to form the elongatetube 42 of the steerable working channel device 40.

The working channel tube 42 can include at least one steering lumen 66in each lateral aspect of the tube 42. The steering wires can be routedfrom the position controller 41 through the steering wire lumens 66through the flexible distal portion 12 and attached to the distal tip13. The distal tip 13 is preferably formed of a harder material 67, suchas a 75 durometer Pellethane, to provide a strong and firm anchor forthe small diameter stainless steel steering wires that may cut through asofter material 68 when retracted. The flexible distal portion 12 caninclude a relatively softer material 68 in each of the lateral aspectsthrough which the steering wire lumens 66 are formed, and a relativelyharder material 67 in the dorsal and ventral aspects of the distalportion 12 tubing. Such a configuration can permit the distal portion 12to deflect in a predetermined manner and amount. The presence of therelatively harder material 67 in the distal portion 12 allows therelatively softer, lateral sections 68 to deflect without compressingwhen extreme deflection is occurring, which can result in exposing aninstrument in the steerable working channel more than desired. Differentrelative durometers of material can be utilized to achieve a relativehardness/softness ratio between sections of the distal portion 12 so asto allow directionally-controlled deflection of the distal portion 12 ofthe working channel tube 42.

When the position controller upper housing portion 50 is rotated, one ofthe steering wires connected to the rotor 55 is wound about the rotor55, causing the distal end of that steering wire to retract. Thisretraction pulls on the lateral side of the distal tip of the workingchannel tube 42 to which it is connected so as to “deflect” the distaltip and distal portion 12 at an angle 57 laterally away from thelongitudinal axis 33 of the working channel tube 42, as shown in FIGS. 9and 10. The position controller upper housing 50 can be rotated in theopposite direction to place tension on, or retract, the other steeringwire and thereby “deflect” the distal portion 12 of the working channeltube 42 in the opposite direction. The position controller 41 can thuscontrol the angular attitude of the distal portion 12 of the workingchannel tube 42. The steering wires in cooperation with the positioncontroller 41 can be configured to limit angular adjustments of thedistal portion 12 to a plane extending generally parallel to the uppersurface of the position controller 41. For example, the configuration ofthe position controller 41 and the steering wires can be such thatangular deflection 57 of the distal portion 12 of the working channeltube 42 can be limited to no more than 30 degrees, 45 degrees, oranother predetermined limit. In other embodiments, various othersteering mechanisms, such as one or more position deflectors associatedwith the working channel tube 42, can be used in accordance with thepresent invention.

In some embodiments, the position controller 41 can include a brakingmechanism (not shown) for securing the upper and lower housing portions50, 51, respectively, into position relative to each other. The brakingmechanism can comprise, for example, a soft polymeric material, such assilicone, coated onto the outer surface(s) of the upper housing rotor 55and/or the lower housing hub 54. In this fashion, the coated surface canallow the rotor 55 to rotate smoothly within the hub 54, while providingsufficient friction to hold the rotor 55 and the hub 54 of the upper andlower housings 50, 51, respectively, in position when released by anoperator. In certain embodiments, in addition to providing a polymericcoating on the rotor 55 and/or hub 54 outer surfaces, one or both ofthese surfaces can be textured so as to provide further friction andgreater securing force between the rotor 55 and hub 54. Such a brakingmechanism is simple, inexpensive, and avoids any need for strongermechanical or gear-based braking mechanisms. In particular embodiments,such a polymeric coating braking mechanism can be combined with otherbraking means.

As will be appreciated, a braking mechanism, of fixing in an alternatemanner, in some embodiments, advantageously allows a predetermined routeof delivery to be established. An advantageous result is increasedprecision and reduced time for procedures. Further, in some embodiments,the steerable working channel may be fixed prior to insertion into apatient.

In certain embodiments, for example, those that include a polymericcoating on the outer surfaces of the rotor 55 and hub 54, the internalbrake mechanism can hold position automatically when steered to aparticular point. This feature provides a physician with a precisecontrol that is maintained when her/his fingers are removed from theposition controller 41, for example, to perform another task during aprocedure.

The position controller 41 can be adapted to control movement (extensionand retraction) of the working channel tube 42 in the proximal anddistal directions. In some embodiments, the inside of the medicalintroducer handle 21 can include detents (not shown) at various stoppoints along the length of the handle 21. For example, the medicalintroducer handle 21 can include a detent at a proximal position 31,medial position 30, and a distal position 29 on the inside of the handle21. The bracket 52 and securing flange 53 on the lower side of theposition controller 41 can slide along the length of the handle 21. Whenthe securing flange 53 reaches a detent, the securing flange 53 engagesthe detent so as to secure the position controller 41 in that position.In this manner, as shown in FIG. 9, the position controller 41 can bemoved in the proximal and distal directions and snap fit into detents atrespective proximal 31, medial 30, and distal 29 positions in the handle21 so as to control the distance the distal tip 13 of the workingchannel tube 42 extends beyond the distal tip 13 of the introducer tube23 of the medical introducer 20. In certain embodiments, the proximalend 31 of the medical introducer handle 21 can include a recess to allowclearance for the working channel tube 42 extending from the proximalend 11 of the steerable working channel device 40, the connection port38, and any attached accessories to slide the entire length of thehandle 21 in the proximal direction.

The position controller 41 can have a size adapted to fit between thefingers and thumb of an operator. In some embodiments, for example, asshown in FIGS. 6 and 7, the center of the position controller 41 caninclude a thumb depression 45, designed to allow a physician to place athumb in the depression 45 to move the position controller 41 in theproximal and distal directions along the length of the medicalintroducer 20. The upper surface of the upper housing 50 of the positioncontroller 41 can include a circular ridge 46 about the center of theposition controller 41. The circular ridge 46 can provide a physician anability to locate the center of the position controller 41 by “feel”rather by having to look at the controller 41.

In some embodiments, as shown for example, in FIGS. 1, 6, and 8, theposition controller 41 can include a plurality of raised ridges, orgrips, 47 on the lateral side edges of upper housing 50. The grip 47surfaces can include a soft, tactile material that can provide improvedgrip and performance with the position controller 41. Such grips 47 canprovide a positive grip on the upper housing 50 for rotating the upperhousing 50 in the process of deflecting the distal portion 12 of theworking channel tube 42.

The steering mechanism can provide the physician sufficient control ofthe distal tip 13 of the elongate tube 42 of the steerable workingchannel device 40 so as to manipulate the distal tip 13 of the workingchannel tube 42 for specific isolation on particular sections of aninterior body region. The steering mechanism can allow the physician tosteer the working channel tube 42 while simultaneously providing accessto a lumen within the steerable working channel for inserting and usingvarious surgical instruments and fluids. That is, the steering mechanismcan provide the control and manipulation of the distal tip 13 theworking channel tube 42 of the steerable working channel device 40needed for use with the surgical instruments and fluids required for aprocedure.

Another feature of some embodiments is that the insertion depth of theworking channel device may be set to a predetermined value using themechanisms described herein for steering and fixing the working channel.

In some embodiments, the steerable working channel device 40 as well canbe controllable independent of the imaging system 60 positioned in themedical introducer 20 and independent of the medical introducer 20. Sucha system can be used in a variety of medical procedures, including, forexample, gynecological, fertility, hysteroscopy, or prostate typeapplications. For example, the medical device introduction system 10 andmedical introducer 20 can be advantageously utilized in procedures andproducts related to insemination, profusion, intrauterineblastocyst/embryo transfer, endoscopic evaluation and operations,laparoscopy (that is, culdoscopy, transvaginal hydro laparoscopy),and/or falloscopy. Accordingly, both fluid management and medicalinstruments usage may be a managed through the working channel device 40independent of or separate from both the imaging system 60 and themedical introducer 20.

In certain embodiments, the separate working channel device40-insertable through a separate lumen 35 in the medical introducer 20from the lumen 34 in which the imaging system 60 is inserted-can be anon-steerable working channel device 40. In such an embodiment, theworking channel device does not have a steering mechanism associatedwith the device 40. However, the non-steerable working channel devicecan be moved in the distal and proximal directions within one of thelumen 35 of the medical introducer 20.

In some embodiments of the separate working channel device 40, theproximal end 11 of the working channel tube 42 can include one or moreaccess ports 38, as shown in FIGS. 1 and 6. Such access ports 38 can besealed with a port seal 39. Such a seal 39 can be formed of anelastomeric material such as silicone rubber and have a very small axialopening through the material that permits a small object such as aneedle to enter, but which otherwise prevents fluid flow in eitherdirection, and thus protects the lumens from receiving contaminatingmaterials therein, in some embodiments, the proximal access 38 on theworking channel tube 42 can comprise a luer lock fitting and seal 44 forcontrollable access to the steerable working channel.

In some embodiments, the imaging system 60 can include an endoscopiccannula 62, a light delivery mechanism, and an imaging device. Theimaging system can include at least one of an optical scope, anultrasound instrument, and/or a camera 61. A camera may be positioned ona distal 12 portion of the endoscopic cannula 62.

In some embodiments, the introducer handle 21 can further include ascope connector 28 located on an opposite side of the handle 21 from theintroducer tube 23 and longitudinally aligned with the one (34) of theplurality of lumens in the introducer tube 23. In this manner theimaging system 60 can be securely connected to the scope connector 28.In this configuration, that is, when the imaging system 60 is securelyconnected to the scope connector 28, the imaging system 60 can rotateindependent of movement of the medical introducer 20.

In some embodiments, the endoscopic cannula, or endoscope, 62 can berigid. In other embodiments, the endoscope 62 can be flexible. Anembodiment of a flexible endoscopic cannula 62 can include a proximal 11portion having a first durometer and a distal 12 portion having a seconddurometer. The second durometer is lower than the first durometer, whichcan allow deflection of the distal portion 12 for improved viewing of atarget area in the interior body region. Some embodiments of the imagingsystem 60 can further include at least two steering wires (not shown),each wire having its distal end connected to the distal tip 13 of theendoscopic cannula 62. The steering wires can extend at least the lengthof the endoscopic cannula 62. The proximal end of the steering wires canbe operably connected to a deflection control mechanism at the proximalend 11 of the endoscopic cannula 62. In this way, actuation of thedeflection control mechanism can cause the distal tip 13 of theendoscopic cannula 62 to deflect at an angle away from the longitudinalaxis 33 of the imaging system 60. The endoscopic cannula 62 can includeeach of a first pair of wires adjacent opposite points on acircumference of the endoscopic cannula 62 to deflect the distal tipalong a first axis. The endoscopic cannula 62 can also include each of asecond pair of wires adjacent two other opposite points on thecircumference of the endoscopic cannula 62. Each of the second pair ofwires can be positioned 90 degrees from each of the first pair of wires,to deflect the distal tip along a second axis perpendicular to the firstaxis.

In some embodiments, the light delivery mechanism can include one ormore light emitting diodes (not shown) mounted at a distal tip of theendoscopic cannula 62. In other embodiments, the light deliverymechanism can include a plurality of light delivery fibers (not shown)attached to the endoscopic cannula 62 and extending from the proximalend 11 to the distal tip 13 of the endoscopic cannula 62. The lightdelivery mechanism can further include a light source (not shown)comprising a light cable attached on one end to a power source and onthe opposite end to the light delivery fibers at the proximal end 11 ofthe endoscopic cannula 62. Alternatively, the light delivery mechanismcan further include a light source comprising one or more light emittingdiodes connected to the light delivery fibers at the proximal end 11 ofthe endoscopic cannula 62. In another embodiment, the light deliverymechanism can include a plurality of light delivery fibers integratedinto the endoscopic cannula 62 that extend from the proximal end 11 tothe distal tip 13 of the endoscopic cannula 62. In this embodiment, thelight delivery mechanism can further include a light source comprising alight cable attached on one end to a power source and on the oppositeend to the light delivery fibers at the proximal end 11 of theendoscopic cannula 62. Alternatively, the light delivery mechanism canfurther include a light source comprising light emitting diodes in theintroducer handle connected, to the light delivery fibers.

In some embodiments, the medical device introduction system 10 of thepresent invention can include an imaging system 60. The imaging system60 can be separate from the medical introducer 20, and can be positionedin a predetermined one (34) of the plurality of lumens of the medicalintroducer 20, for example, in the dedicated scope lumen 34. The scopelumen 34 can be configured to receive various types of imaging systems60 therein. The imaging system 60 can be removably connected to themedical introducer 20.

As described herein, in various embodiments of the medical deviceintroduction system 10, the imaging system 60 can be operatedindependent of the medical introducer 20 and/or the working channeldevice 40, thereby permitting a steady, or constant, view of aparticular anatomical structure or site in an interior body region whilethe introducer 20 and/or the working channel device 40 are manipulated.Such an independent operation of the imaging system 60 can beaccomplished, for example, through cooperation of the imaging system 60with the scope port, or connector, 28 as shown in FIGS. 1-3.

The scope connector 28 is fixed to, for example, by being integrallymolded with, the proximal end 14 of the medical introducer handle 21.The scope connector 28 can be positioned in longitudinal alignment withthe dedicated scope lumen 34 in the introducer manifold 22. The scopeconnector 28 can include a molded luer lock fitting, which allows thescope 62 to be securely connected to the introducer handle 21, and toalso rotate about its longitudinal axis 33 independent from movement ofthe medical introducer 20. In an application in which the scope 62 isnot secured to the introducer handle 21, the imaging system 60 can alsobe rotated about its longitudinal axis 33 independent from movement ofthe medical introducer 20. In this way, the medical introducer 20 and/orthe working channel device 40 associated therewith can be moved withoutmoving the imaging system 60. As a result, the view through the imagingsystem 60 can remain constant, providing a fixed reference point formovement of the introducer 20 and/or working channel device 40, andthereby allowing the physician to maintain a steady, right-side-uporientation of view and movement in the interior body region.

The imaging system 60 can comprise, for example, an optical scope, suchas a fiber optic scope, a camera 61, a charge couple device (CCD), acamera positioned on the distal tip 13 and/or distal portion 12 of anelongate shaft (62), known as a “chip-on-a-stick,” or ultrasound orother sonic device. The imaging system 60 can include a light source(not shown) for illuminating an interior body region. The light sourcecan be separate from, and removably connected to, the imaging system 60.Alternatively, the light source can be integrated with the imagingsystem 60. As shown in the embodiment in FIGS. 1, 3, and 11, the imagingsystem 60 can include a fiberscope 62 operably connected to an ocularmechanism, such as an endoscope lens 63, to adjust focus or lightintensity. The fiberscope 62 can be, for example, a 2.0 mm 50 Kfiberscope, and the endoscope lens 63 can be a 2.9 mm 30 degree rodlens. As shown in this embodiment, the imaging system 60 can be a “lowprofile” camera 61, which is less bulky, weighs less, and more easilymaneuverable than other cameras, and is configured to readily cooperatewith other components of the medical device introduction system 10.

The imaging system 60 can be connected to a monitor or other displaymechanism for viewing an image within at least a portion of the interiorbody region into which the imaging system 60 is inserted. The imagingsystem 60 can be connected to an image capture mechanism, for example, acomputer-readable medium such as a computer hard drive, a memory stick,a compact disc, a digital versatile disc, magnetic tape, or otherstorage medium, for recording images viewed via the imaging device.

In another aspect of the present disclosure, as shown, for example, inFIG. 33, the imaging system 60 may comprise a body member 400 includinga light source 425 configured to emit light. A flexible elongate tubularmember 450 has a proximal portion 450A operably engaged with the bodymember 400, and extends to an opposed distal portion 450B. An imagingdevice 475 (see, e.g., FIG. 35) is engaged with the distal portion 450Bof the tubular member 450 and is configured to be in communication withthe body member 400. The imaging device 475 is arranged with respect tothe distal portion 450B of the tubular member 450 so as to be directed,and to be capable of capturing an image, in an imaging direction 480outwardly of the distal portion 450B. A plurality of light transmissiondevices 500 is operably engaged with and extends from the light source425 and through the tubular member 450 to respective distal ends 505thereof disposed about the distal portion 450B of the tubular member450. The light transmission devices 500 are configured to receive thelight from the light source 425 and to transmit the light to the distalends thereof 505, such that the light is emitted from the distal ends505. The distal ends 505 of the light transmission devices 500 arearranged about the imaging device 475, about the distal portion 450B ofthe tubular member 450, so as to direct the light transmitted from thelight source 425 in the imaging direction 480, outwardly of the distalportion 450B of the tubular member 450.

In some instances, the flexible elongate tubular member 450 maycomprise, for example, a braided elastic filiform material configured totransmit torque between the proximal and distal portions 450A, 450B ofthe tubular member 450. The braided elastic filiform material maycomprise, for instance, a stainless steel braided sleeve or hose, thougha braided filiform material of various types could also be used (i.e.,by varying the arrangement of the braiding or weaving) to providedesirable characteristics in terms of the ability to transmit torque,while maintaining the desirable flexibility of the tubular member 450along the length thereof. The tubular member 450 is preferablysufficiently flexible, at least about the distal portion 450B thereof,to conform to the curvature of the distal portion 12 of the introducertube 23, as disclosed elsewhere herein. In other instances, if necessaryor desired, a rigid elongate conduit 440 may be engaged between the bodymember 400 and the flexible elongate tubular member 450 so as to becapable of transmitting torque between the body member 400 and theflexible elongate tubular member 450. In still other instances, ifnecessary or desired, the rigid elongate conduit 440 may extend over theflexible elongate tubular member 450 about the engagement thereof withthe body member 400. In further instances, the tubular member 450 maycomprise an external polymeric sheath 460 disposed externally to thebraided filiform material 455 and/or an internal polymeric sheath 465disposed internally to the braided filiform material 455 (see, e.g.,FIG. 34). Such polymeric sheaths 460, 465 may comprise separate anddiscrete tubes that may be coaxially arranged with the braided filiformmaterial 455. In other instances, the polymeric sheaths 460, 465 may beengaged with the braided filiform material, for example, in aco-extrusion or coating process. In some instances, as further disclosedherein, the tubular member 450 may be employed to carry a plurality oflight transmission devices (i.e., light delivery fibers) therein and, assuch, it may be desirable for the external and/or internal polymericsheaths 460, 465 to be opaque to preserve the light transmitted by thelight transmission devices 500 through the distal ends 505 thereof.

In some aspects, the tubular member 450 may further comprise a terminalmember 525 engaged with the braided filiform material 455 about thedistal portion 450B of the tubular member 450. That is, termination ofthe braided filiform material 455 may result in loose/protrudingfilaments of the braided material. Accordingly, the terminal member 525may be applied to cap or seal the terminus of the braided filiformmaterial 455, for instance, to prevent such loose/protruding filaments.However, the terminal member 525 may also be configured to receive andsecure the imaging device 475 and/or the distal ends 505 of the lighttransmission devices 500.

In one aspect, the light transmission devices 500 may comprise fiberoptic elements or light delivery fibers. In another aspect, the imagingdevice 475 may comprise an active-pixel sensor array or a ComplementaryMetal-Oxide Semiconductor (CMOS) sensor. It may be desirable, in someinstances, for the imaging device 475 to capture images substantially inreal time or at least with minimal delay between image capture anddisplay. In such aspects, the imaging device 475 may be configured as aquadrilateral, generally configured to be received within a lumendefined by an inner wall (i.e., the braided filiform material 455 or theinternal polymeric sheath 465) of the tubular member 450. In suchinstances, it may be preferable that the imaging device 475 be receivedand arranged so as to be disposed perpendicularly to a longitudinal axisof the tubular member 450 (i.e., the longitudinal axis of the tubularmember 450 extends perpendicularly through the plane of the imagingdevice 475). Further, in general, the lumen defined by the tubularmember 450 has a non-polygonal cross-section. That is, the lumen definedby the tubular member 450 may be configured to have, for example, acircular, oval, or ovate cross-section. In some particular instances,the imaging device 475 may be configured as a square (i.e., having adiagonal dimension of about 2.3 mm), and is received within a lumenconfigured to have a circular cross-section having, for example, aninner diameter of about 2.3 mm (see, e.g., FIG. 35), and the lighttransmission devices 500 may comprise fiber optic elements or lightdelivery fibers having the distal ends 505 thereof arranged about theimaging device 475 in the segments of the circular lumen unoccupied bythe imaging device 475. In such a configuration, the unoccupied segmentsabout the imaging device 475 may each include the distal ends 505 of aplurality of fiber optic elements or light delivery fibers. In thismanner, significant illumination may be directed from the distal ends ofthe light transmission devices 500 outwardly of the distal portion 450Bof the tubular member 450, in the imaging direction 480, for improvingthe images captured by the imaging device 475. One skilled in the artwill thus appreciate that the imaging device 475 and the distal ends 505of the light transmission devices 500 arranged about the imaging device475 may be disposed within the lumen defined by the tubular member 450.However, one skilled in the art will also appreciate that the imagingdevice 475 and the distal ends 505 of the light transmission devices 500arranged about the imaging device 475 may be engaged with or mounted tothe terminal member 525, with the terminal member 525, in turn, engagedwith or mounted to the distal portion 450B of the tubular member 450. Inthe latter, it may also be preferred that the imaging device 475,configured as a square, is engaged with or mounted to the terminalmember 525 configured to have a circular cross-section (see, e.g., FIG.35), wherein the distal ends 505 of the light transmission devices 500(i.e., fiber optic elements or light delivery fibers) are arranged aboutthe imaging device 475 in the segments of the circular terminal member525 unoccupied by the imaging device 475.

Due to the disposition of the imaging device 475 about the distalportion 450B of the tubular member 450, the imaging system 60 mayfurther comprise a communication element 550 operably engaged with thebody member 400 (i.e., so as to minimize the footprint of the imagingdevice 475). The communication element 550 may be configured andarranged to be in signal communication with the imaging device 475, forexample, so as to receive an image signal therefrom associated with theimage captured thereby or to communicate electrical power to the imagingdevice 475. For instance, the imaging device 475 may be configured to bein wireless communication with the communication element 550 comprisinga wireless transceiver. In other instances, the imaging device 475 maybe in communication with the communication element 550 by way of a wiredor wireline communication extending between the imaging device 475 andthe communication element 550, through the tubular member 450. Thecommunication element 550 may comprise any arrangement suitable forreceiving image signals from the imaging device 475, and for directingelectrical power to the imaging device 475. The communication element550 may also be configured or comprise elements suitable to direct theimage signal externally to the imaging system 60, such as, for instance,to an external display device 575 or computer device 600. In suchinstances, minimizing the components included in the imaging system 60may allow the imaging system 60 to be a single-use device (i.e.,disposable) from an economic standpoint. Otherwise, the imaging system60 may be configured so as to promote effective sterilization andre-use.

In particular aspects, the imaging system 60 may also comprise a displaydevice 575 (i.e., a monitor, tablet computer, or smartphone) fordisplaying the image associated with the image signal received from thecommunication element 550 and/or a computer device 600 (i.e., tabletcomputer, laptop, or desktop computer) for storing or analyzing theimage associated with the image signal received from the communicationelement 550. The display device 575 and/or the computer device 600 maybe in communication with the communication element 550 (i.e., a circuitboard having appropriate circuitry), for example, via a wiredcommunication arrangement or a wireless communication arrangement.

Since the light source 425 may be carried by the body member, in someinstances, the imaging device 60 may also include a power source 625operably engaged with the body member 400, wherein the power source 625is arranged to at least be in electrical communication with the lightsource 425. In some aspects, it may also be desirable for the powersource 625 to be in electrical communication with the imaging device475. The power source 625 may comprise a self-contained power source,such as a battery, capacitor, or other suitable source of electricity,so as to promote portability of the imaging system 60. In otherinstances, however, the power source 625 may be in electricalcommunication with the light source 425 and/or the imaging device 475via a wired arrangement. In aspects including a self-contained powersource 625, such as a battery, the power source 625 may be removablysecured to the body member 400 (i.e., to promote separate and discreterecharging of the battery, or so as to allow one battery to be readilyreplaced with another). For example, a magnetic connector arrangement orany other suitable removably securement arrangement may be providedbetween the power source 625 and the body member 400. In some particularaspects, the removably secured power source 625 may also carry the lightsource 425, wherein the light source 425 would be configured andarranged to engage the light transmission elements 500 upon engagementof the power source 625 with the body member 400. In any instance, inthe event that the electrical power provided by the power source 625results in resistive heating, the power source 625 may, in someinstances, comprise a heat shield 650 at least partially surrounding thepower source 625.

Aspects of an imaging device 60, as illustrated in FIG. 33, can thus beapplied as a component of a medical device introduction system 10, asotherwise disclosed herein, or as part of an associated device, kit,method of use, or method of manufacture, as will be appreciated by aperson skilled in the art. More particularly, a medical deviceintroduction system 10 implementing such an imaging system 60 may beconfigured to include a medical introducer 20 comprising a handle 21 andan elongate introducer tube 23 extending from the handle 21 to a distalend 12, wherein the introducer tube 23 includes and defines a pluralityof lumens extending longitudinally therein from the handle 21 to thedistal end 12. The imaging system 60, as shown in FIG. 33, may thus bearranged such that the body member 400 is configured to be received bythe handle 21, and the tubular member 450 is configured to be insertablethrough the handle 21 and positionable in one of the lumens (34) so asto extend to the distal end 12 of the introducer tube 23. In aspectsimplementing a rigid elongate conduit 440, the conduit 440 may beconfigured to be received by the handle 21 and the tubular member 450may be configured to be received by the one of the lumens (34) of theintroducer tube 23. In any aspect, the distal end 13 of the medicalintroducer 20 may be configured as a compound curve, and at least thedistal portion 450B of the tubular member 450 is configured to flexduring longitudinal movement of the tubular member 450 within the one ofthe lumens (43) to conform to the compound curve of the distal end 13 ofthe medical introducer 20.

In some such aspects of the present invention, a securing device/scopeconnector 28 may be engaged with the handle 21 of the medical introducer20, wherein the scope connector 28 is configured to receive the tubularmember 450 therethrough. The securing device/scope connector 28 isconfigured to secure the tubular member 450 such that the imaging device475 is disposed in a selected longitudinal position along the introducertube 23 and such that the tubular member 450 is rotatable about alongitudinal axis thereof within the introducer tube 23. That is, insome instances, it may be desirable for the tubular member 450 to befixed in a particular longitudinal position with respect to theintroducer tube 23 such that the imaging device 475 is positioned asdesired with respect to the distal portion 12/distal tip 13 of theintroducer tube 23. At the same time, it may be desirable for thetubular device 450 to be rotatable about the longitudinal axis thereofwith respect to the introducer tube 23, for example, so as to maintainthe horizon of the image captured by the imaging device 475, as themedical introducer 20 is manipulated. In some instances, the securingdevice/scope connector 28 may comprise, for example, a compressionfitting engaged with the handle 21, coaxially with the longitudinalaxis, wherein the compression fitting is configured to be rotatableabout the longitudinal axis. As such, the compression fitting may besecured to the tubular member 450 when the imaging system 60 is engagedwith the handle 21 in the desired longitudinal position, wherein thestructure of the compression fitting then allows the tubular member 450to be rotated about the longitudinal axis, as necessary or desired. Infacilitating the reception of the imaging system 60 by the medicalintroducer 20, a mounting interface/slide member or mechanism 71 may beoperably engaged with the handle 21 and configured to receive and secureat least the body member 400 of the medical imaging system 60 such thatthe medical imaging system 60 and the medical introducer 20 are movablerelative to each other (i.e., such that the body member 400 is supportedby the slide member 71 as the tubular member 450 is moved along theintroducer tube 23, or as the body member 400 is rotated about thelongitudinal axis to, in turn, rotate the tubular member 450 within theintroducer tube 23).

Embodiments of medical device introduction systems and methods of thepresent invention provide advantages over conventional systems andmethods. The cooperation of the medical introducer 20, related to, forexample, the modular introducer handle 21 and introducer tube 23 andfluid delivery in dedicated lumens 36; the separate steerable workingchannel device 40, including ease of introduction of accessory devicesand precision of device positioning and utilization through the workingchannel; the separate imaging system 60 delivered through a dedicatedlumen 34; and the control of each of the medical introducer 20,steerable working channel device 40, and imaging system 60 independentof each other device provide for effectiveness of operation.

Such medical device introduction systems and methods of the presentinvention can allow a physician, or other medical personnel, to controland manipulate the working channel device 40, an imaging source 60, andother medical devices inserted into an interior body region through themedical introducer 20, while simultaneously using surgical tools andfluids needed for such procedures. In this manner, the physician may beallowed to positionally locate, isolate, and view problem areas withgreater precision within the interior body region than with conventionalmedical device introduction systems and methods. That is, control ofvisualization, access, and use of instrumentation in the operative siteenvironment can be enhanced by the cooperation of the variouscombinations of components as described herein. In part due to thesimple design, embodiments of the present invention can be easy to useand thus may require minimal training. Such factors can allow aphysician to utilize embodiments of the present invention to performprocedures in an office setting which may have previously been avoideddue to complexity and cost.

In particular, the ability to maintain a constant, or fixed, point ofreference, for example, by keeping the imaging system 60 steady whilere-positioning the medical introducer 20 and/or the working channeldevice(s) 40 can provide greater control over the medical procedure, andmay decrease operative time. Embodiments of medical device introductionsystems 10, devices 20, kits, and methods of the present invention canbe utilized in conjunction with procedures that are minimally invasive.Whether used alone or in the context of minimally invasive proceduresembodiments of the present invention can advantageously provide, forexample, performing the procedure on an outpatient basis, reduced traumato the target area, reduced anesthesia time, reduced recovery time, anddecreased discomfort to the patient. As an example, in a hysteroscopysystem, an embodiment of the present invention can allow a fixedendoscope 62 position, thereby minimizing tissue trauma as compared toconventional hysteroscopy procedures. In addition, minimal outsidediameters of the medical introducer 20 and associated componentsresulting in smaller devices can decrease the need for anesthesia andcan increase patient comfort related to a procedure.

Single use components can be safer than reusable devices due to thedecrease or elimination of risk for transmission of communicableinfections and diseases between patients. Single use components can bemore cost-effective due to elimination of cleaning and sterilizationexpense and decreased expense for repairs associated with reusabledevices.

In another aspect of the present invention, certain embodiments of themedical introducer 20 can further include a lift wire not shown)attached on its proximal end to a distal tip lift control (not shown),such as a knob similar to the steerable working channel device positioncontroller 41. The lift wire can be routed through a dedicated lift wirelumen 69, as shown in FIG. 13, through the length of the medicalintroducer tube 23 and attached on its distal end to the distal tip 13of the introducer tube 23. The distal lift control can be moved in theproximal direction so as to pull the lift wire in the proximaldirection, thereby deflecting the distal tip 13 of the introducer tube23 in one direction. When the distal tip 13 of the introducer tube 23 islifted, any device therein will also be lifted, or deflected, along withthe introducer tube 20. In operation, the introducer tube 20 can beinserted in the straight position (along its longitudinal axis).

In an exemplary embodiment, a flexible medical device, such as aflexible hysteroscope, can be inserted in the working channel, or lumen,35 of the medical introducer 20. Once the introducer tube 23 is insertedin the straight position into the uterine cavity 64 (FIG. 10) and thecavity 64 distended, the distal tip lift control can be moved in theproximal direction so as to lift the distal tip of the introducer tube23 in one direction. The introducer 20 can then be rotated to view theextreme left and right aspects of the uterine cavity 64. The distal tipof the introducer tube 23 can be further positioned and aligned with thetubal osteum for delivery of an instrument or implant to the fallopiantube 65. Such an embodiment can thus provide a simple operation forlifting, or deflecting, a steerable working channel device 40, imagingsystem 60, or other medical device in an interior body region.

Some embodiments of a medical device introduction system 10 of thepresent invention can include an accessory device support 70, as shownin FIG. 15. The accessory device support 70 can be removably connectedto the introducer handle 21. The accessory device support 70 cancomprise a carrier arm 72 for supporting an upper part of a body of aseparate medical device 73 to be used with the medical introducer 20,and a slide member (or mechanism) 71 for slidably supporting a lowerpart of the body of the separate medical device 73. This accessorydevice support 70 can be used to stabilize placement of additionalseparate medical devices (73) in the interior body region. In certainembodiments, the accessory device support 70 can be removably connectedto the outside surface of the scope connector 28 on the proximal end ofthe introducer handle 21.

An embodiment of the present invention can include a delivery catheterhaving a small delivery channel, or working lumen 35, as shown in FIG.14. Such a configuration allows the scope lumen 34 to be larger than,for example, the embodiment shown in FIG. 5. In the embodiment shown inFIG. 14, the catheter can be inserted into the interior body region inthe straight position. For example, a flexible hysteroscope can beintroduced into the uterine cavity 64 in the straight position via asmall delivery catheter. Once inserted, and the cavity 64 is distended,the medical introducer 20 can be rotated to provide an optimal viewingangle. The flexible hysteroscope can have a pre-formed “angle up” distaltip 13, and can be inserted via the working delivery channel in anobturator. Once in the uterine cavity 64, the obturator can be removed,and the angled distal tip is restored for use. This enables a zerodegree angle of view flexible scope to be utilized and a more effectiveaccess approach to particular pathologies. Such a small diameterdelivery catheter can assist visualization and access in difficult toreach pathology. In addition, a small diameter catheter can improvepatient comfort relative to larger delivery catheters.

As shown in FIG. 16, an embodiment of the present invention can includea continuous flow examination sheath 80. This device 80 can besingle-use and utilized for quick evaluation or hysteroscopy, forexample. The continuous flow examination sheath 80 can include a formeddistal tip 81, an insertion portion 82, a fluid-out adapter 84, afluid-in adapter 83, a finger grip 85, a proximal port 86, and an innersheath 87. An endoscope 62 can be inserted through the proximal port 86through a fluid seal adapter (not shown). The fluid-in tube 83 can allowa physician to deliver fluid to clear the scope 62 lens or distend theuterine cavity 64 for improved visualization. In addition, the fluid-outadapter 84, and tube, can allow the physician to clear fluid from thecavity 64 that may impair viewing caused by blood present at the site.

As shown in FIG. 17, an embodiment of the present invention can includea single flow examination sheath 90. This device 90 can be single-useand utilized for quick evaluation or hysteroscopy, for example. Thesingle flow examination sheath 90 can include a formed distal tip 81, aninsertion portion 82, a fluid-in adapter 83, a finger grip 85, aproximal port 86, and a nose piece 91. An endoscope 62 can be insertedthrough the proximal port 86 through a fluid seal adapter. The fluid-intube 83 can allow a physician to deliver fluid to clear the scope lensor distend the uterine cavity 64 for improved visualization.

As shown in FIG. 18, an embodiment of the present invention can includea pre-formed delivery catheter 100. The pre-formed delivery catheter 100can include a formed distal tip 81, an insertion portion 82, an adapter101, a finger grip 85, a proximal port 86, and a nose piece 91. Thisdevice 100 can be used for delivering another medical device ortreatment to a specific site when a steerable mechanism is notpractical. Fluid can be incorporated by adapters known in the art, forexample, a Touhy Borst adapter and a side port entry attached to theproximal end of the catheter 100.

In another embodiment, an endoscopy system utilized in the presentinvention can be a wireless handheld endoscopy system (not shown). Sucha system can include an endoscopic cannula 62, a disposable mount, afocus/zoom function, a wireless camera, for example, a 2.4 GHz, highresolution camera used in cooperation with a laptop or other monitor,and controls for imaging and power.

Some embodiments of a medical device introduction system 10 can beutilized with a conventional endoscope trocar system (not shown), forexample, for abdominal minimally invasive surgery. The medicalintroducer 20 can be inserted through a 10 mm or 5 mm trocar and can besealed by the internal trocar seal. When inserted with a conventionaltrocar system, embodiments of the present invention can retain allfunctionality described herein, including depth adjustment for themedical introducer 20, 360 degrees of rotation, depth adjustment for thesteerable working channel device 40, and angle and direction ofdeflection adjustment, visualization, and access related to the workingchannel device 40.

Some embodiments of the present invention can include a kit comprisingone or more of various components of a medical device introductionsystem 10, including a medical introducer 20, a separate imaging system60, and/or a separate working channel device 40. The medical introducer20 can include a handle 21 and an elongate introducer tube 23 extendingfrom the distal end 15 of the handle 21. The introducer tube 23 caninclude a plurality of lumens 34, 35, 36 extending longitudinallytherein. The medical introducer 20 may be inserted into an interior bodyregion of a patient. The separate imaging system 60 may be insertedthrough the handle 21 and positioned in a predetermined one (34) of theplurality of lumens. The imaging system 60 can have an interface withthe handle 21 such that each of the imaging system 60 and the medicalintroducer 20 is movable independent of the other. The separate workingchannel device 40 can include an working channel tube 42 and a positioncontroller 41. The working channel tube 42 can include at least onelumen extending the length thereof defining a working channel. Theposition controller 41 can be configured to control positioning of theworking channel tube 42. The working channel device 40 may be removablyconnectable to the handle 21 and positioned in another predetermined one(35) of the plurality of lumens. In some embodiments of a kit of thepresent invention, each of the medical introducer 20, the imaging system60, and the working channel device 40 can be movable independent of theother.

In certain embodiments, the medical introducer handle 21 can comprise anoval-shaped ring of material having an open interior. The handle 21 canhave a proximal end 14 configured to receive at least one fluid tube 24,25 and the imaging system 60 therethrough. The handle 21 can furtherinclude a distal end 15 adapted to connect to the introducer tube 23. Incertain embodiments, the plurality of lumens in the introducer tube 23can include a scope lumen 34, at least one working lumen 35, and atleast one fluid lumen 36 separate from the scope lumen 34 and theworking lumen(s) 36. In an illustrative embodiment, the medicalintroducer 20 can further include a fluid inflow tube 24 routed throughthe proximal end 14 of the handle 21 and in fluid communication with afluid lumen 36, and a fluid outflow tube 25 routed through the proximalend 14 of the handle 21 and in fluid communication with another fluidlumen 36.

In some embodiments, the medical introducer 20 can include a modularmanifold 22 integrally formed on the proximal end 11 of the introducertube 23 and have a corresponding plurality of lumens 34, 35, 36 alignedwith the plurality of lumens 34, 35, 36 in the introducer tube 23. Themanifold 22 can be removably connected to the introducer handle 21 suchthat the manifold 22 and introducer tube 23 are interchangeable in thehandle 21 with other manifolds 22 and introducer tubes 23. In particularembodiments, a kit can include a plurality of manifolds 22 andintroducer tubes 23, such that one manifold 22 and introducer tube 23 ina kit may be interchanged on a handle 21 with another one of themanifolds 22 and introducer tubes 23 in the kit.

In some embodiments, the medical introducer 20 and/or the workingchannel device 40 can be disposable. In some embodiments, at least aportion of the medical introducer 20 and/or at least a portion of theworking channel device 40 can be translucent such that passage ofmaterials therethrough is viewable.

In some embodiments, one or more of the introducer tube 23, the workingchannel tube 42, and the endoscopic cannula 62 can include a proximal 11portion having a first durometer and a distal 12 portion having a seconddurometer. The second durometer is lower than the first durometer so asto allow deflection of the distal 12 portion of the respective tube orcannula for controllable access to a target area in the interior bodyregion.

In certain embodiments, the working channel device 40 can be a steerableworking channel device 40. In such an embodiment, the working channeltube 42 can comprise a flexible distal portion 12 for steering toselected positions. The position controller 41 can be operably connectedto the working channel tube distal 12 portion and slidable within theintroducer handle 21 for moving the working channel tube distal 12portion in distal and proximal directions. In addition, the positioncontroller 41 be actuated to steer the flexible distal 12 portion of theworking channel tube 42 in predetermined directions and amounts.

In some embodiments, the imaging system 60 can include an endoscopiccannula 62, a light delivery mechanism (not shown), and a imagingsystem. The light delivery system can comprise light emitting diodesand/or light delivery fibers. The imaging system can be an optical scope62, an ultrasound instrument, or a camera 61.

In certain embodiments, a kit can include other devices and/orinstruments that may be used with the medical device introduction system10. For example, such a kit may include an accessory device support 70removably connectable to the outside surface of a scope connector 28 onthe proximal end 14 of the introducer handle 21. The accessory devicesupport 70 can comprise a carrier arm 72 for supporting an upper part ofa body of a separate medical device 73 to be used with the medicalintroducer 20 and a slide member 71 for slidably supporting a lower partof the body of the separate medical device 73. Such an accessory devicesupport 70 may be used to facilitate and stabilize placement of aseparate medical device 73 in the interior body region.

The present invention can include embodiments of a method. For example,a medical introducer 20 comprising a handle 21 and an introducer tube 23extending therefrom and having a plurality of lumens 34, 35, 36extending longitudinally therein can be inserted into an interior bodyregion of a patient. A separate imaging system 60 can be insertedthrough the handle 21 and in a predetermined one of the plurality oflumens 34, 35, 36. The imaging system 60 can be positioned in a selectedposition within the interior body region. Then, an image can be producedfrom within the interior body region. A separate working channel device40 and position controller 41 can be removably connected to the medicalintroducer 20. The working channel device 40 can include an workingchannel tube 42 having at least one lumen extending the length thereofdefining a working channel. The position controller 41 for controllingthe position of the working channel tube 42 can be positioned in theworking channel in another predetermined one (35) of the plurality oflumens. In such embodiments, one of the group of the medical introducer20, the imaging system 60, and the working channel device 40 may bemoved independently of the others of the group.

In some embodiments of a method, the medical introducer handle 21 cancomprise an oval-shaped ring of material having an open interior. Themethod can further include connecting a distal end of the handle 21 tothe introducer tube 23. In some embodiments of a method, the medicalintroducer 20 can include a modular manifold 22 integrally formed on aproximal end 11 of the introducer tube 23 and have a correspondingplurality of lumens 34, 35, 36 aligned with the plurality of lumens 34,35, 36 in the introducer tube 23. In such an embodiment, the manifold 22can be removably connected to the introducer handle 21. The manifold 22and introducer tube 23 may be interchanged in the handle 21 with othermanifolds 22 and introducer tubes 23.

In an embodiment, a slider 191 and rail 192 may be used in conjunctionwith a medical device 190 to accommodate the handle of the medicaldevice 190. For example, the slider 191 and rail 192 may be used toaccommodate a medical device 190 such as that disclosed in U.S. Pat. No.8,079,364, which is herein incorporated by reference in its entirety.The rail 192 is designed so as to accommodate the slider 191 so as toserve as a means of holding the medical device 190. In one embodiment,the slider 191 and the rail 190 when serving as a holder of the medicaldevice 190 means that fewer hands are needed in surgery. Without theslider 191 and rail 192, a nurse or some other personnel is needed tohold the medical device 190 to prevent the medical device from turningwhen inserted into a cavity (for example, into the uterine cavity).Thus, the slider 191 and rail 192 stabilizes the handle without havingadditional hands having to hold the device.

For example, when a fallopian tube sterilization is performed, often anurse is required to hold the handle of a medical device 190 while thesurgeon operates the device so as to insert an additional medical deviceor to perform some procedure (such as cauterization or the like). Byusing the slider 191 and rail 192, the nurse is no longer required tohold the device as the surgeon performing the surgery is able to notonly manipulate the distal tip of the medical device to perform thesterilization by inserting the tip through the one or more osteums intothe fallopian tube, but is also able to hold the medical device due tothe presence of the slider 191 and rail 192. The nurse or other medicalpersonnel is then available to perform other duties (such as helping theanesthesiologist or providing the necessary medical devices to thesurgeon).

The uterine cavities in all patients tend to be slightly different. Thelocations of the osteum may differ slightly from patient to patientmeaning that the location of the fallopian tubes may also differ. In oneembodiment, the slider 191 and rail 192 may be able to accommodate amedical device 190 that contains a steerable distal tip for a workingchannel device. The slider 191 and rail 192 in combination with thesteerable distal tip allow the surgeon to use a scope to identify thelocation of the osteum(s) and then to insert a medical device, anexample of which is disclosed in U.S. Pat. No. 7,921,848. U.S. Pat. No.7,921,848 is herein incorporated by reference in its entirety.

In an embodiment, rather than having a steerable distal tip, the distaltip of the medical device may be bent. When performing a femalesterilization such as a tubal ligation or a tubal occlusion the bentdistal tip may make it easier to access the osteum. Other proceduresthat can be done include diagnostic hysteroscopy, polypectomy,myomectomy, a directed uterine biopsy, fundal biopsy, endometrialharvesting or tubal patency. See for example, the bent distal tip asshown in FIG. 20. In one embodiment, the angle at which the distal tipis disposed cannot be altered. In other embodiments, the distal tip maybe part of the introducer tube that can be bent and thus, altered. Whenthe introducer tube cannot be altered, an osteum (or either of the twoostei) can be accessed by adjusting the distance that the workingmedical device is inserted into the vagina. When a more acute angle isdesired, the surgeon will pull the medical device out more and when aless acute angle is desired, the surgeon will push more of the medicaldevice into the uterus. In any event, by this methodology, the ostei andfallopian tubes can be accessed.

In a variation of this embodiment, the diameter of introducer tube 23 inthis embodiment may be less than the diameter of an introducer tube of amedical device that has a steerable distal tip. This is because theworking channel medical device no longer requires the mechanismnecessary for steering the distal tip. Accordingly, components such asthe steering and/or lift wires that are necessary in a steerable workingchannel medical device are not required to move the distal tip.

In an alternative embodiment, a sheath that has an inner diameter thatis slightly larger than the outer diameter of the working channelmedical device may be placed over the distal end of the introducer tube.In several embodiments, the sheath may be bent and may be of sufficientstructural integrity so that the sheath also bends the distal end of themedical device to the same degree as the sheath. In one embodiment, asurgeon may use a sheath that is bent at an angle that is 10 degreesfrom straight. If a scope is associated with the working channel medicaldevice, the surgeon may view the inside of the uterus to ascertain therelative locations of the ostei. There may be other sheaths that arebent at any of a plurality of degrees from straight that can then beinserted over the introducer tube so the appropriate orientation isrealized to allow access to the ostei. For example, there may be bentsheaths that may be 10 degrees, 20 degrees, 30 degrees, or 40 degreesfrom straight. By selecting the correct sheath (after ascertaining theorientation to approach the ostei), the surgeon can most readily performthe procedure in the fallopian tube that is to be performed. An exampleof the bent sheath can be seen in FIGS. 21 and 22. FIGS. 23 and 24 showthe bent sheath with the introducer tube and the working channel medicaldevice approaching the left osteum and left fallopian tube (FIG. 23) andthe right osteum and right fallopian tube (FIG. 24). In an embodiment,one might access the right osteum after accessing the left osteum merelyby turning the handle 180 degrees (which in turn changes the orientationof the distal tip from accessing the left osteum to being able to accessthe right osteum or vice versa).

In an embodiment, the present medical device does not rely on the distaltip being correctly oriented by a steerable working channel medicaldevice but rather relies rather on the distal tip of the introducer tubebeing bent or alternatively, a sheath that fits over the introducer tubethat is bent. When the sheath is bent, it has sufficient structuralstability so as to bend the distal tip of the working channel medicaldevice. The advantage of these systems is that they require lessmanipulation at the proximal end of the medical device by the surgeon.The proper orientation is achieved simply by having the correct bend inthe introducer tube or the sheath that is designed to accommodate theintroducer tube. When the system employing a sheath is used, this systemhas the advantage that different orientations of the distal tip can beachieved simply by having a plurality of different sheaths that are allbent to slightly different degrees. It should be noted that theorientation may be slightly modified from the plurality of bent sheathsby the relative position of the sheath as it relates to the introducertube. The closer the sheath is to the proximal end of the medicalinstrument (closer to the surgeon), the larger the bend of the distaltip end. That is, by having the bend closer to the proximal end, thedistal tip will be a further distance from straight.

FIGS. 26 A and B show two different embodiments of the presentinvention, the “r” curved embodiment and the “s” curved embodiment,respectively. FIG. 26 B shows an introducer with a compound-curved tip261 that allows the positioning of an imaging device further from anobject 262 relative to the simple curve 260. When the introducer isinserted into a small body cavity or vessel, different views of ananatomical site can be attained. The view angle profile of theanatomical site is indicated in both FIGS. 26 A and B by dotted lines265 and 265′. Note that because the viewing angles are the same, thefurther distance 264 of the compound curve relative to the lesserdistance 263 of the simple curve allows the user to view more areaaround the object 262. Nevertheless, in either embodiment, the object262 to be addressed can be done with steerable working channel 266.

In one embodiment, the compound-curved introducer distal tip (theintersection of dotted lines 265 and 265′) is positioned at a distance264 that is 3-10 mm further from the object 262 (such as an osteum) thana simple curved introducer tip distance 263. The embodiment in FIG. 26 Bprovides more space for the steerable working channel 266 to extend(deploy) out of the distal tip of the introducer and as well as space tobe steered (articulated) or deflected within the field of view (265 and265′) of the imaging device and to place in alignment with the tubalosteum to deliver an implant, instrument, energy source, or to performsome therapeutic procedure. The simple-curved device of FIG. 26Aprovides less working space for a steerable working channel between theintroducer distal tip and the object (e.g., the osteum).

In some embodiments, and as shown in FIGS. 27 and 28, the medicalintroducer 20 can include a modular manifold 271 integrally formed onthe proximal end 11 of the introducer tube 23 and having a correspondingplurality of parallel aligned lumens 34, 35, 36 in the introducer tube23. The manifold can incorporate seal(s) 292 (see FIG. 29) to preventfluid flow from out of a body cavity or vessel when no instrumentationis in the working channel 35. The seal(s) 290 do(es) not allow fluid orgas flow from a distal position to a proximal position through specifiedlumens in the introducer tube 23 but may allow fluid and/or gas to flowin the opposite direction.

The specified lumens in the modular manifold 271 are created by joininga manifold base 291 and a manifold cover 292 (see FIGS. 29 and 30) withthe seal 290 (shown in FIG. 29 but not shown in FIG. 30) positioned inthe interior of the combined manifold base 291 and manifold cover 292.The manifold base 291, manifold cover 292 and introducer tube 23 can beassembled to form integrally isolated lumens corresponding with theplurality of lumens 34, 35, 36 and introducer tube 23 by aligning theplurality of lumens 34, 35, 36 with sized Teflon core pins 301 (seeFIGS. 30 and 31), which hold the relative positions of the plurality oflumens 34, 35, 36 and the introducer tube 23 in place. In an embodiment,one can inject/insert UV curable glue 321 (see FIG. 32) into theassembly at junction 323 between the manifold base 291 and manifoldcover 292. The introducer tube 23 with lumen core pins 301 and themodular manifold 271 are all held in a vertical position when insertingthe glue (see FIG. 32). The assembly is held in a vertical position soas to allow the passage of the glue by gravity down into the manifoldcover 292, which also secures the seal 290 (not shown in FIG. 32) inplace. The transparent assembly is subsequently then exposed to UV lightto cure the UV glue injected between manifold base 291 and introducertube 23 contained by cover 292. The core pins 301 can then be removedfrom the modular manifold 271 containing integral seal(s) 290.

In one embodiment, the seal 290 is situated and is of a type so as toallow the passage of fluid in a direction that is from the proximal endof the introducer medical device to the distal end of the introducermedical device but does not allow passage of fluid in the otherdirection. In another embodiment, the seal may allow passage of fluid inthe other direction. In another embodiment, the seal may prevent passageof fluid at all, or allow only the passage of low viscosity fluids whilesubstantially blocking the passage of medium and/or high viscosityfluids.

Certain embodiments of a method of the present invention includeperforming a medical procedure in an interior body region through theworking channel device 40. For example, the medical procedure can be agynecological procedure, a spinal procedure, or other procedure.

In some embodiments, a kit comprises at least one of a medicalintroducer; an imaging device; or a working channel device. In someembodiments a kit comprises a medical introducer and a working channeldevice. In some embodiment a kit comprises a working channel deviceinserted into a medical introducer.

The devices, systems, kits, and methods embodying the present inventioncan be adapted for use in many suitable interior body regions in humansand animals, wherever it may be desirable to provide support for atissue. The illustrative embodiments are described in association withdevices, systems, kits, and methods used, to access interior bodyregions such as the uterine cavity 64. For example, the medical deviceintroduction system 10, and, in particular, the cooperating medicalintroducer 20, steerable working channel device 40, and imaging system60 can be utilized to perform a hysteroscopy.

Some embodiments of the present invention may be utilized inapplications other than those described herein. In some embodiments, thepresent invention may be used in other interior body regions or types oftissue. For example, certain embodiments of a medical deviceintroduction system 10 of the present invention can be adapted for usein procedures related to the spinal column, for example, in the epiduralspace. In a particular embodiment, for example, the medical deviceintroduction system according to the present invention may be utilizedin an upright ventral epiduroscopic laser discectomy, in which theprocedure is performed with the patient in an upright, symptomaticposition such that diagnosis and treatment can be performedinteractively with axial loading pressure on the affected intervertebraldisc.

Features of a medical device introduction system and methods of thepresent invention may be accomplished singularly, or in combination, inone or more of the embodiments of the present invention. Althoughparticular embodiments have been described, it should be recognized thatthese embodiments are merely illustrative of the principles of thepresent invention. Those of ordinary skill in the art will appreciatethat a medical device introduction system 10 and method of the presentinvention may be constructed and implemented in other ways andembodiments. For example, in all cases, any of the features that aredisclosed herein can be combined with any of the other features that aredisclosed (even if those two or more distinct features appear indifferent sections of the above written, description). Accordingly, thedescription herein should not be read as limiting the present invention,as other embodiments also fall within the scope of the presentinvention.

That which is claimed:
 1. A medical device introduction system adaptedto be at least partially insertable into an interior body region of apatient, the system comprising: a medical introducer comprising a handleand an elongate introducer tube extending from the handle to a distalend, the introducer tube defining a plurality of lumens extendinglongitudinally therein from the handle to the distal end; and a medicalimaging system configured to be operably engageable with the medicalintroducer, and comprising: a body member including a light sourceconfigured to emit light, the body member being configured to bereceived by the handle; a flexible elongate tubular member having aproximal portion operably engaged with the body member, and extending toan opposed distal portion, the tubular member being configured to beinsertable through the handle and positionable in one of the lumens soas to extend to the distal end of the introducer tube; an imaging deviceengaged with the distal portion of the tubular member and configured tobe in communication with the body portion, the imaging device beingarranged so as to be directed, and to be capable of capturing an image,in an imaging direction outwardly of the distal portion; and a pluralityof light transmission devices extending from the light source andthrough the tubular member to respective distal ends thereof disposedabout the distal portion of the tubular member, the light transmissiondevices being configured to receive the light from the light source andto transmit the light to the distal ends thereof, the distal ends of thelight transmission devices being arranged about the imaging device aboutthe distal portion of the tubular member so as to direct the lighttransmitted from the light source in the imaging direction.
 2. Thesystem of claim 1, comprising a rigid conduit engaged between the bodymember and the flexible elongate tubular member so as to be capable oftransmitting torque between the body member and the flexible elongatetubular member, the conduit being configured to be received by thehandle and the tubular member being configured to be received by the oneof the lumens of the introducer tube.
 3. The system of claim 1,comprising a securing device engaged with the handle of the medicalintroducer and configured to receive the tubular member therethrough,the securing device being configured to secure the tubular member suchthat the imaging device is disposed in a selected longitudinal positionalong the introducer tube and such that the tubular member is rotatableabout a longitudinal axis thereof within the introducer tube.
 4. Thesystem of claim 3, wherein the securing device comprises a compressionfitting engaged with the handle, coaxially with the longitudinal axis,so as to be rotatable about the longitudinal axis.
 5. The system ofclaim 1, wherein the light transmission devices comprise fiber opticelements or light delivery fibers.
 6. The system of claim 1, wherein theimaging device comprises an active-pixel sensor array or a ComplementaryMetal-Oxide Semiconductor (CMOS) sensor.
 7. The system of claim 1,wherein the imaging device is configured as a quadrilateral, and isreceived within a lumen defined by an inner wall of the tubular member,perpendicularly to a longitudinal axis of the tubular member, with thelumen being configured to have a circular, oval, or ovate cross-section.8. The system of claim 1, wherein the imaging device is configured as asquare, and is received within a lumen defined by an inner wall of thetubular member, perpendicularly to a longitudinal axis of the tubularmember, with the lumen being configured to have a circularcross-section, and wherein the light transmission devices comprise fiberoptic elements or light delivery fibers having the distal ends thereofarranged about the imaging device in the segments of the circular lumenunoccupied by the imaging device.
 9. The system of claim 1, comprising apower source operably engaged with the body member, wherein the powersource is arranged to be in electrical communication with the lightsource.
 10. The system of claim 9, wherein the power source is removablysecured to the body member via a magnetic connector arrangement.
 11. Thesystem of claim 9, comprising a heat shield surrounding the powersource.
 12. The system of claim 1, comprising a communication elementoperably engaged with the body member, the communication element beingin signal communication with the imaging device so as to receive animage signal therefrom associated with the image captured thereby or tocommunicate electrical power to the imaging device.
 13. The system ofclaim 12, comprising a display device for displaying the image or acomputer device for storing or analyzing the image, the display deviceor the computer device being in communication with the communicationelement via a wired communication arrangement or a wirelesscommunication arrangement.
 14. The system of claim 1, wherein theflexible elongate tubular member comprises a braided elastic filiformmaterial configured to transmit torque between the proximal and distalportions of the tubular member.
 15. The system of claim 14, wherein thetubular member comprises an external polymeric sheath disposedexternally to the braided filiform material or an internal polymericsheath disposed internally to the braided filiform material.
 16. Thesystem of claim 15, wherein the external polymeric sheath and theinternal polymeric sheath are opaque to preserve the light transmittedby the light transmission devices.
 17. The system of claim 14, whereinthe tubular member comprises a terminal member engaged with the braidedfiliform material about the distal portion of the tubular member, theterminal member being configured to receive and secure the imagingdevice and the distal ends of the light transmission devices.
 18. Thesystem of claim 1, comprising a mounting interface operably engaged withthe handle and configured to receive and secure at least the body memberof the medical imaging system such that the medical imaging system andthe medical introducer are movable relative to each other.
 19. Thesystem of claim 1, wherein the distal end of the medical introducer isconfigured as a compound curve, and wherein at least the distal portionof the tubular member is configured to flex during longitudinal movementof the tubular member within the one of the lumens to conform to thecompound curve of the distal end of the medical introducer.
 20. Amedical imaging system adapted to be at least partially insertable intoan interior body region of a patient, the system comprising: a bodymember including a light source configured to emit light; a flexibleelongate tubular member having a proximal portion operably engaged withthe body member, and extending to an opposed distal portion; an imagingdevice engaged with the distal portion of the tubular member andconfigured to be in communication with the body member, the imagingdevice being arranged so as to be directed, and to be capable ofcapturing an image, in an imaging direction outwardly of the distalportion; and a plurality of light transmission devices extending fromthe light source and through the tubular member to respective distalends thereof disposed about the distal portion of the tubular member,the light transmission devices being configured to receive the lightfrom the light source and to transmit the light to the distal endsthereof, the distal ends of the light transmission devices beingarranged about the imaging device about the distal portion of thetubular member so as to direct the light transmitted from the lightsource in the imaging direction.
 21. The system of claim 20, comprisinga rigid elongate conduit engaged between the body member and theflexible elongate tubular member so as to be capable of transmittingtorque between the body member and the flexible elongate tubular member.22. The system of claim 20, wherein the light transmission devicescomprise fiber optic elements or light delivery fibers.
 23. The systemof claim 20, wherein the imaging device comprises an active-pixel sensorarray or a Complementary Metal-Oxide Semiconductor (CMOS) sensor. 24.The system of claim 20, wherein the imaging device is configured as aquadrilateral, and is received within a lumen defined by an inner wallof the tubular member, perpendicularly to a longitudinal axis of thetubular member, with the lumen being configured to have a circular,oval, or ovate cross-section.
 25. The system of claim 20, wherein theimaging device is configured as a square, and is received within a lumendefined by an inner wall of the tubular member, perpendicularly to alongitudinal axis of the tubular member, with the lumen being configuredto have a circular cross-section, and wherein the light transmissiondevices comprise fiber optic elements or light delivery fibers havingthe distal ends thereof arranged about the imaging device in thesegments of the circular lumen unoccupied by the imaging device.
 26. Thesystem of claim 20, comprising a power source operably engaged with thebody member, wherein the power source is arranged to be in electricalcommunication with the light source.
 27. The system of claim 26, whereinthe power source is removably secured to the body member via a magneticconnector arrangement.
 28. The system of claim 26, comprising a heatshield surrounding the power source.
 29. The system of claim 26,comprising a communication element operably engaged with the bodymember, the communication element being in signal communication with theimaging device so as to receive an image signal therefrom associatedwith the image captured thereby or to communicate electrical power tothe imaging device.
 30. The system of claim 29, comprising a displaydevice for displaying the image or a computer device for storing oranalyzing the image, the display device or the computer device being incommunication with the communication element via a wired communicationarrangement or a wireless communication arrangement.
 31. The system ofclaim 20, wherein the flexible elongate tubular member comprises abraided elastic filiform material configured to transmit torque betweenthe proximal and distal portions of the tubular member.
 32. The systemof claim 31, wherein the tubular member comprises an external polymericsheath disposed externally to the braided filiform material or aninternal polymeric sheath disposed internally to the braided filiformmaterial.
 33. The system of claim 32, wherein the external polymericsheath and the internal polymeric sheath are opaque to preserve thelight transmitted by the light transmission devices.
 34. The system ofclaim 31, wherein the tubular member comprises a terminal member engagedwith the braided filiform material about the distal portion of thetubular member, the terminal member being configured to receive andsecure the imaging device and the distal ends of the light transmissiondevices.
 35. A method of forming a medical imaging system adapted to beat least partially insertable into an interior body region of a patient,the method comprising: operably engaging a proximal portion of aflexible elongate tubular member with a body member including a lightsource configured to emit light, the tubular member extending to anopposed distal portion; engaging an imaging device with the distalportion of the tubular member such that the imaging device is incommunication with the body member, and such that the imaging device isarranged to be directed, and to be capable of capturing an image, in animaging direction outwardly of the distal portion; and engaging aplurality of light transmission devices with the light source such thatthe light transmission devices extend through the tubular member torespective distal ends thereof disposed about the distal portion of thetubular member, the light transmission devices being configured toreceive the light from the light source and to transmit the light to thedistal ends thereof, and such that the distal ends of the lighttransmission devices are arranged about the imaging device about thedistal portion of the tubular member to direct the light transmittedfrom the light source in the imaging direction.
 36. The method of claim35, comprising engaging a rigid elongate conduit between the body memberand the flexible elongate tubular member for transmitting torque betweenthe body member and the flexible elongate tubular member.
 37. The methodof claim 35, wherein engaging the plurality of light transmissiondevices with the light source comprises engaging fiber optic elements orlight delivery fibers with the light source.
 38. The method of claim 35,wherein engaging the imaging device with the distal portion of thetubular member comprises engaging an active-pixel sensor array or aComplementary Metal-Oxide Semiconductor (CMOS) sensor with the distalportion of the tubular member.
 39. The method of claim 35, whereinengaging the imaging device with the distal portion of the tubularmember comprises engaging the imaging device, configured as aquadrilateral, with a lumen defined by an inner wall of the tubularmember, perpendicularly to a longitudinal axis of the tubular member,the lumen being configured to have a circular, oval, or ovatecross-section.
 40. The method of claim 35, wherein engaging the imagingdevice with the distal portion of the tubular member comprises engagingthe imaging device, configured as a square, with a lumen defined by aninner wall of the tubular member, perpendicularly to a longitudinal axisof the tubular member, with the lumen being configured to have acircular cross-section, such that the light transmission devices,comprising fiber optic elements or light delivery fibers, have thedistal ends thereof arranged about the imaging device in the segments ofthe circular lumen unoccupied by the imaging device.
 41. The method ofclaim 35, comprising operably engaging a power source with the bodymember, such that the power source is in electrical communication withthe light source.
 42. The method of claim 41, wherein operably engagingthe power source with the body member comprises removably securing thepower source to the body member via a magnetic connector arrangement.43. The method of claim 41, comprising engaging a heat shield with thepower source so as to surround the power source.
 44. The method of claim35, comprising engaging a communication element with the body member, insignal communication with the imaging device, for receiving an imagesignal therefrom associated with the image captured thereby or forcommunicating electrical power to the imaging device.
 45. The method ofclaim 44, comprising engaging a display device for displaying the image,or a computer device for storing or analyzing the image, intocommunication with the communication element via a wired communicationarrangement or a wireless communication arrangement.
 46. The method ofclaim 35, wherein operably engaging the proximal portion of the flexibleelongate tubular member comprises operably engaging the proximal portionof the flexible elongate tubular member, comprising a braided elasticfiliform material, with the body member, the braided filiform materialbeing configured to transmit torque between the proximal and distalportions of the tubular member.
 47. The method of claim 46, comprisingengaging an external polymeric sheath with an external portion of thebraided filiform material or engaging an internal polymeric sheath withan internal portion of the braided filiform material.
 48. The method ofclaim 47, wherein engaging a polymeric sheath with the braided filiformmaterial comprises engaging an opaque polymeric sheath with the braidedfiliform material to preserve the light transmitted by the lighttransmission devices.
 49. The method of claim 46, comprising engaging aterminal member with the braided filiform material about the distalportion of the tubular member, wherein the terminal member is configuredto receive and secure the imaging device and the distal ends of thelight transmission devices.